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| Name | Class |
|---|---|
| NCM USA | UNKNOWN |
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The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.
This is a prospective, Phase 2, single center study of participants with Neuroendocrine Tumors (NETs). Study participants will receive 68Ga-DOTATOC. DOTATOC is a somatostatin analogue that localizes on the somatostatin receptors expressed by NETs and is attached to a radioactive material called Gallium 68. Participants will undergo a PET/CT imaging study to investigate 68Ga-DOTATOC's suitability as a positron emission tomography (PET) imaging agent for NETs. The radiation (imaging) dose will be 111-185 megabecquerel (MBq) (3 - 5 mCi) ± 25%. All doses after labeling will be presented in buffered solution for intravenous injection. Imaging will start 90 ±30 minutes after injection.
Sensitivity and specificity of this imaging technique will be compared with those of conventional imaging modality including CT, MRI and In-111 Octreoscan performed within 6-12 months before or after PET/CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-DOTATOC PET/CT | Experimental | Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATOC | Drug | The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity to Correctly Diagnose NET | Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging. | During imaging process ( approximately 120 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity to Detect True Negative | A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET). |
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Inclusion Criteria:
Signed informed consent.
Patients of either gender, aged ≥18 years.
Karnofsky status ≥60.
Life expectancy of at least 12 weeks.
Histologically and/or clinically confirmed and/or suspicious of NET.
A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available.
Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks.
Recent Blood test results up to 4-6 weeks as follows:
Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or older.
Negative pregnancy test in women capable of child-bearing.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charito Love, MD | Montefiore Medical Center | Principal Investigator |
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Participants were recruited at Montefiore Medical Center which has medical specializing in the diagnosis and treatment of NETs. Eligible participants were those referred by their physicians for PET (Positron Emission Tomography) or CT imaging due to suspected or confirmed NETs.
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| ID | Title | Description |
|---|---|---|
| FG000 | 68Ga-DOTATOC PET/CT | Study participants will receive Gallium 68 (68Ga)-DOTATOC and undergo a PET/CT imaging study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
68Ga-DOTATOC PET/CT will be compared with final diagnoses for sensitivity, specificity and accuracy for detecting NET primary lesion and/or metastases. Results will be compared with conventional imaging results.
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| ID | Title | Description |
|---|---|---|
| BG000 | 68Ga-DOTATOC PET/CT | Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study to measure its ability to detect primary NET and any metastasis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity to Correctly Diagnose NET | Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging. | Posted | Number | percent of NET correctly diagnosed | During imaging process ( approximately 120 minutes) |
|
The somatostatin analogue being administered is a short acting agent that, if it caused an adverse effect, would be seen within a few minutes after administration. Participants were monitored for one hour after injection. Participants were systematically assessed and questioned regarding changes in sensation or appearance of new symptom.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 68Ga-DOTATOC PET/CT | Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charito Love, MD | Montefiore Medical Center | 718-406-8462 | clove@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2016 | Sep 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C499142 | Ga(III)-DOTATOC |
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| During imaging process ( approximately 120 minutes) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Conventional Imaging | All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) or In-111 Octreoscan as standard care prior to 68Ga-DOTATOC imaging. |
|
|
| Secondary | Specificity to Detect True Negative | A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET). | Posted | Number | percent of tumors identified as non-NET | During imaging process ( approximately 120 minutes) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D009380 | Neoplasms, Nerve Tissue |