| Primary | Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants) | Subject-level sensitivity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants).
- TP participants were those who showed at least one lesion based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read.
- FN participants were those who did not show any lesions based on [68Ga]Ga-DOTA-TATE PET/CT imaging but showed at least one lesion based on CIM by central read.
True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN] | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are CIM positive participants (TP or FN participants). | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
| | | Title | Denominators | Categories |
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| True Positive [TP] | | | | False Negative [FN] | | |
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| Primary | Number of [68Ga]Ga-DOTA-TATE Negative Participants (TN Participants) Among CIM Negative Participants (TN or FP Participants) | Subject-level specificity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants).
- TN participants were those who did not show any lesions based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read.
- FP participants were those who showed at least one lesion based on [68Ga]Ga-DOTA-TATE PET/CT imaging but did not show any lesions based on CIM by central read.
True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN] | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are CIM negative participants (TN or FP participants). | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Primary | Subject-level Sensitivity | Subject-level sensitivity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN] Sensitivity = TP / (TP + FN) | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are CIM positive participants (TP or FN participants). | Posted | | Number | 95% Confidence Interval | Sensitivity (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Primary | Subject-level Specificity | Subject-level specificity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants). True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN] Specificity = TN / (TN + FP). | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are CIM negative participants (TN or FP participants). | Posted | | Number | 95% Confidence Interval | Specificity (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Number of Participants Who Are Positive on Both [68Ga]Ga-DOTA-TATE PET/CT Imagings and CIM (TP Participants) Among Participants Who Are Positive on [68Ga]Ga-DOTA TATE PET/CT Imaging (TP or FP Participants) | Subject-level positive predictive values (PPV) is defined as the proportion of TP participants among [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP or FP participants). | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are positive on [68Ga]Ga-DOTA TATE PET/CT imaging (TP or FP participants). | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Number of Participants Who Are Negative on Both [68Ga]Ga-DOTA-TATE PET/CT Imaging and CIM (TN Participants) Among Participants Who Are Negative on [68Ga]Ga-DOTA-TATE PET/CT Imaging (TN or FN Participants) | Subject-level NPV was defined as the proportion of TN participants among [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN or FN participants). | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are negative on [68Ga]Ga-DOTA-TATE PET/CT imaging (TN or FN participants). | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Subject-level PPV | Subject-level positive predictive values (PPV) is defined as the proportion of TP participants among [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP or FP participants). PPV (Subject-level positive predictive values) = TP / (TP + FP) | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP or FP participants). | Posted | | Number | 95% Confidence Interval | PPV (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Subject-level NPV | Subject-level NPV was defined as the proportion of TN participants among [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN or FN participants). NPV (Subject-level negative predictive values) = TN / (TN + FN) | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact, and who are [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN or FN participants). | Posted | | Number | 95% Confidence Interval | NPV (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Participants Who Have Consistent Results (i.e. TP or TN Participants) Among All Participants Assessed by [68Ga]Ga-DOTA-TATE PET/CT Imaging and CIM - Subject-level Accuracy | Subject-level accuracy is defined as the proportion of TP and TN participants among all patients in the EFF (i.e. TP+TN+FP+FN participants). Accuracy = (TP + TN) / (TP + TN + FP + FN). | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Number | 95% Confidence Interval | Accuracy (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Region-level Sensitivity | Region-level sensitivity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging positive regions (TP regions) among CIM positive regions (i.e. TP or FN regions). Sensitivity = TP / (TP + FN) | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Number | 95% Confidence Interval | Sensitivity (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Region-level Specificity | Region-level specificity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging negative regions (TN regions) among CIM negative regions (i.e. TN or FP regions). Specificity = TN / (TN + FP) Note: Even when a participant is categorized as positive in subject-level, he/she can still have negative results in region-level. e.g. When only Liver is positive and other regions are negative, the participant is categorized as positive in subject-level. As all participants had at least one CIM-negative region and were included in the table, the number of participants analyzed is 71. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Number | 95% Confidence Interval | Specificity(%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Region-level Positive Predictive Values (PPV) | Region-level PPV is defined as the proportion of regions which are positive on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM (TP regions) among [68Ga]Ga-DOTA-TATE PET/CT imaging positive regions (i.e. TP or FP regions). Region-level positive predictive values (PPV) = TP / (TP +FP) | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Number | 95% Confidence Interval | PPV (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Region-level Negative Predictive Values (NPV) | Region-level NPV is defined as the proportion of regions which are negative on both [68Ga]Ga- DOTA-TATE PET/CT imaging and CIM (TN regions) among [68Ga]Ga-DOTA-TATE PET/CT imaging negative regions (i.e. TN or FN regions). Region-level negative predictive values (NPV) = TN / (TN + FN) Note: Even when a participant is categorized as positive in subject-level, he/she can still have negative results in region-level. e.g. When only Liver is positive and other regions are negative, the participants is categorized as positive in subject-level. As all participants had at least one negative region by Ga-DOTA-TATE PET/CT and were included in the table, the number of participants analyzed = 71. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Number | 95% Confidence Interval | NPV (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Region-level Accuracy | Region-level accuracy is defined as the proportion of regions which are CIM and [68Ga]Ga-DOTA-TATE PET/CT imaging positive (TP regions) or negative (TN regions) among regions detected by CIM and [68Ga]Ga-DOTA-TATE PET/CT imaging (i.e. TP+TN+FP+FN regions). Accuracy = (TP + TN) / (TP + TN + FP + FN). | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Number | 95% Confidence Interval | accuracy (%) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Region-level True Positive | TP regions were the regions which showed at least one lesion based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Region-level False Negative | FN regions were the regions which did not show any lesions based on [68Ga]Ga-DOTA-TATE PET/CT imaging but show at least one lesion based on CIM by central read. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Region-level False Positive | FP regions were the regions which showed at least one lesion based on [68Ga]Ga-DOTA-TATE PET/CT imaging but do not showed any lesion based on CIM by central read. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Region-level True Negative | TN regions were the regions which did not show any lesion based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires | Numbers of participants for each intended treatment plan collected from physician at pre and post [68Ga]Ga-DOTA-TATE PET/CT imaging will be summarized. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM, with a valid measurement without a protocol deviation with impact. Patients with confirmed/suspected NENs) | Posted | | Count of Participants | | Participants | | Before and after imaging on Day 1 | | | | ID | Title | Description |
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| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging | The assessment of [68Ga]Ga-DOTA-TATE PET/CT images set was compared among the 3 independent readers. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Inter-reader Variability (%) on [68Ga]Ga-DOTA-TATE PET/CT Imaging | Inter-reader variability for [68Ga]Ga-DOTA-TATE PET/CT imaging is defined as agreement rate among reader determinations. As assessed by Fleiss' Kappa statistics. Inter-reader variability (%) and its normality 95% CI is presented. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Number | 95% Confidence Interval | Inter-reader variability (%) | | Day 1 | | | | ID | Title | Description |
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| OG000 | All Participants | Confirmed/suspected NENs + HVs. All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration | An adverse event (AE) is any untoward medical occurrence (e.g., any occurrence of unfavorable and unintended sign(s), symptom(s) or medical condition, including abnormal laboratory findings, or worsening of any pre-existing sign(s), symptom(s) or medical condition) in a participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of any treatment used in this study. This includes events reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative). | The Safety Set comprised all participants who received any dose of [68Ga]Ga-DOTA-TATE. | Posted | | Count of Participants | | Participants | | For treated pts: AEs are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days. For HV pts: AEs are reported from the study start plus 8 days, up to a maximum timeframe of 9 days. | | | | ID | Title | Description |
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| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-inf) will be listed and summarized using descriptive statistics. | PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min) | | | | ID | Title | Description |
|---|
| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUClast will be listed and summarized using descriptive statistics. | PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min) | | | | ID | Title | Description |
|---|
| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Observed Maximum Plasma Concentration (Cmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics. | PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min) | | | | ID | Title | Description |
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| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Time of Maximum Observed Drug Concentration Occurrence (Tmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics. | PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers. | Posted | | Median | Full Range | hour | | Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min) | | | | ID | Title | Description |
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| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Terminal Elimination Half-life (T1/2) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-live will be listed and summarized using descriptive statistics. | PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour | | Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min) | | | | ID | Title | Description |
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| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Total Systemic Clearance for Intravenous Administration (CL) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. CL will be listed and summarized using descriptive statistics. | PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min) | | | | ID | Title | Description |
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| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Vz will be listed and summarized using descriptive statistics. | PAS - pharmacokinetics analysis set - for treated participants with a valid measurement without a protocol deviation with impact. PK analysis was planned to be performed on a small subset of patients only, 6, and not healthy volunteers. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L | | Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min) | | | | ID | Title | Description |
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| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available | The lesion-level concordance rate for SSTR between [68Ga]Ga-DOTA-TATE PET/CT imaging local read and local histopathology result among legions which is available, will be calculated. The rate is defined as the proportion of lesions which are positive or negative on both local read of [68Ga]Ga-DOTA-TATE PET/CT imaging and local histopathology among lesions detected by local histopathology. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Number | | lesions | | Day 1 to Day 30 | | | | ID | Title | Description |
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| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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| Secondary | Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available - Concordance Rate | The lesion-level concordance rate for SSTR between [68Ga]Ga-DOTA-TATE PET/CT imaging local read and local histopathology result among legions which is available, will be calculated. The rate is defined as the proportion of lesions which are positive or negative on both local read of [68Ga]Ga-DOTA-TATE PET/CT imaging and local histopathology among lesions detected by local histopathology. | The Efficacy Analysis Set (EFF) comprised all enrolled participants who were administered with [68Ga]Ga-DOTA-TATE. Patients with confirmed/suspected NENs had to have both results of [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM. HVs had to have results of [68Ga]Ga-DOTA-TATE PET/CT imaging, with a valid measurement without a protocol deviation with impact. | Posted | | Number | 95% Confidence Interval | Concordance rate (%) | | Day 1 to Day 30 | | | | ID | Title | Description |
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| OG000 | [68Ga]Ga-DOTA-TATE / Confirmed/Suspected NENs | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) | | OG001 | Healthy Volunteers | All eligible participants received [68Ga]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi) |
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