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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
| Royal Marsden NHS Foundation Trust | OTHER |
| University of Manchester | OTHER |
| The Christie NHS Foundation Trust |
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Radiolabelled somatostatin analogs are invaluable in the diagnosis and treatment of neuroendocrine tumours (NET). The most common positron emission tomography (PET) radiotracers used for the visualisation of NET are radiolabelled somatostatin analogs (SSAs) labelled with [68Ga]Ga-DOTA-peptides. However, [68Ga]Ga-DOTA-peptide radiolabelled SSAs have significant limitations in terms of accessibility and low throughput. The team at Imperial College London developed a novel radiotracer, [18F]fluoroethyl triazole labelled [Tyr3]-Octreotate analogue ([18F]-FET-βAG-TOCA), in an attempt to overcome these limitations. The FETONET study was designed to have 3 parts. The FETONET study was designed to have 3 parts. Part A evaluated the biodistribution, dosimetry and safety of [18F]FET-βAG-TOCA. Uptake was assessed at multiple time points over a 4 hour period. The data was analysed and an optimal imaging time point determined. Part B of the FETONET study involved the performance of whole body static [18F]FET-βAG-TOCA PET-CT imaging, at the optimal time point previously established, within a larger cohort of patients. Part C comprised a prospective non-inferiority study that analysed the [18F]FET-βAG-TOCA PET/CT data collected within Part A & Part B and compared this to standard of care [Ga68]Ga-DOTA-peptide PET-CT imaging.
Neuroendocrine tumours (NET) are tumours derived from enterochromaffin cells, which are characterised by the expression of somatostatin receptors (SSTRs) on their surface. These tumours release substances into systemic circulation, resulting in episodic flushing, wheezing, diarrhoea, and eventual right-sided valvular heart disease. All of these symptoms negatively impact on patients' quality of life. The management of NET is primarily determined by the stage of disease. For patients with localised or limited disease the primary modality of therapy is surgery. Whilst patients with metastatic disease, undergo systemic therapy with palliative intent. Accurate imaging is therefore central to the management of this disease. Whilst computed tomography (CT) is useful in the localisation of NET, nuclear imaging using tumour-specific radiolabelled receptors are considerably more sensitive and specific methods for detecting NET and their metastases. The most commonly used positron emission tomography (PET) radiotracers used for the visualisation of NET are radiolabelled somatostatin analogs (SSAs) labelled with [68Ga]Ga-DOTA-peptides. The [68Ga]Ga-DOTA-peptide radiolabelled SSAs have significant limitations in terms of accessibility and low throughput. The team at Imperial College London developed a novel radiotracer, [18F]fluoroethyl triazole labelled [Tyr3]-Octreotate analogue ([18F]-FET-βAG-TOCA), in an attempt to overcome these limitations. The FETONET study was designed to have 3 parts. The FETONET study was designed to have 3 parts. Part A evaluated the biodistribution, dosimetry and safety of [18F]FET-βAG-TOCA. Uptake was assessed at multiple time points over a 4 hour period. The data was analysed and an optimal imaging time point determined. Part B of the FETONET study involved the performance of whole body static [18F]FET-βAG-TOCA PET-CT imaging, at the optimal time point previously established, within a larger cohort of patients. Part C comprised a prospective non-inferiority study that analysed the [18F]FET-βAG-TOCA PET/CT data collected within Part A & Part B and compared this to standard of care [Ga68]Ga-DOTA-peptide PET-CT imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: [18F]-FET-βAG-TOCA-PET/CT performed in patients with histologically-confirmed NET. | Experimental | Patients with histologically-confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic [18F]FET-βAG-TOCA imaging at multiple time points over a 4 hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. |
|
| Part B: [18F]FET-βAG-TOCA PET/CT compared with [68Ga]Ga-DOTA-peptide PET/CT in patients with NET. | Experimental | Patients with histologically confirmed neuroendocrine tumours (NET) underwent PET/CT imaging with both [18F]FET-βAG-TOCA and [68Ga]Ga-DOTA-peptide. The two PET/CT scans were performed within a 6-month time period. Whole-body static [18F]FET-βAG-TOCA PET/CT scan performed at 50 minutes post radiotracer injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-FET-βAG-TOCA | Drug | Single I.V. administration of a [18F]fluoroethyl triazole [Tyr3]Octreotate ([18F]-FET-βAG-TOCA). Patients will receive a maximum injected dose of 370MBq and will subsequently undergo PET/CT imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. | Mean residence time (MRT) was used to characterise the biodistribution of [18F]-FET-βAG-TOCA throughout the body. Mean residence time is a pharmacokinetic/uptake parameter that describes the average length of time a radiotracer resides within the body, or a particular organ, before being eliminated. Understanding MRT helps researchers to determine how long a radiotracer remains in the system, which is crucial for drug dosing, therapeutic efficacy, and potential toxicity assessment. | Baseline (on day of scan over 4 hours) |
| To Calculate the Effective Dose (ED) of [18F]-FET-βAG-TOCA | Effective dose is an estimate of the overall risk of potential harm from exposure to ionising radiation. ED takes into account, the absorbed dose to all organs of the body, the relative harm level of the radiation and the sensitivities of each organ to radiation. ED may help in understanding the risk of potential long-term health effects from radiation exposure, such as the risk of developing cancer later in life. The unit of measure for ED is millisievert per megabecquerel (mSv/MBq), which refers to the effective dose (amount of radiation absorbed by the body) per unit of activity administered. | Baseline (on the day of the scan over 4 hours) |
| To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA | Standardised uptake value (SUV) is a semiquantitative measurement of radiotracer uptake in tissue. It is a ratio that compares the activity concentration in a specific region of interest to the activity concentration in the whole body. SUVmax is the highest value of the SUV measured within a region of interest. | Baseline (on the scan day over 4 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare the Diagnostic Efficacy of [18F]-FET-βAG-TOCA PET/CT With Standard of Care Somatostatin Receptor Imaging in Patients With a Histological Diagnosis of NET. | To determine the clinical utility of [18F]-FET-βAG-TOCA-PET/CT compared with standard of care [68Ga]Ga-DOTA-peptide imaging. Standardised uptake value (SUV) is a semiquantitative measurement of radiotracer uptake in tissue. It is a ratio that compares the activity concentration in a specific region of interest to the activity concentration in the whole body. SUVmax is the highest value of the SUV measured within a region of interest. The median SUVmax of [18F]-FET-βAG-TOCA and [68Ga]-DOTA-peptide per anatomic region were calculated to determine diagnostic efficacy. Diagnostic efficacy is the ability of a test to correctly identify a disease or condition when it's present and correctly identify the absence of a disease when it's not present. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rohini Sharma | Imperial College London | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27173162 | Background | Dubash SR, Keat N, Mapelli P, Twyman F, Carroll L, Kozlowski K, Al-Nahhas A, Saleem A, Huiban M, Janisch R, Frilling A, Sharma R, Aboagye EO. Clinical Translation of a Click-Labeled 18F-Octreotate Radioligand for Imaging Neuroendocrine Tumors. J Nucl Med. 2016 Aug;57(8):1207-13. doi: 10.2967/jnumed.115.169532. Epub 2016 May 12. | |
| 38331457 |
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There is no plan to make individual participant data available to other researchers.
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Recruitment Period: 14May2014-17Oct2018. The FETONET study was designed to have 3 parts. Part A evaluated the biodistribution, dosimetry and safety of [18F]FET-βAG-TOCA. Uptake was assessed at multiple time points and an optimal time point determined. Part B utilised this time point within a larger cohort. Part C comprised a prospective non-inferiority study analysing the [18F]FET-βAG-TOCA PET/CT data collected during Parts A & B and comparing this to [Ga68]Ga-DOTA-peptide PET-CT imaging.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Patients With Histologically-confirmed NET. | Patients with histologically-confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic [18F]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4 hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of [18F]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of [18F]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body [18F]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 & 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A. |
| FG001 | Part B: [18F]-FET-βAG-TOCA-PET/CT Compared With [68Ga]Ga-DOTA-peptide PET/CT in Patients With NET. | Patients with histologically confirmed neuroendocrine tumours (NET) underwent PET/CT imaging with both [18F]-FET-βAG-TOCA and [68Ga]Ga-peptide. The two PET/CT scans were performed within a 6-month time period. Whole-body static [18F]-FET-βAG-TOCA PET-CT imaging was conducted 50 minutes post-injection. The maximum dose of [18F]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part B of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of the [18F]-FET-βAG-TOCA (Maximum injected dose of 370MBq)
Total effective dose: 9 mSv In Part B of the FETONET study, one low-dose attenuation CT scan was performed per patient. Whereas, two low-dose attenuation CT scans were performed per patient in Part A. The total effective dose per patient was therefore lower in Part B. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A |
| |||||||||||||
| Part B |
| |||||||||||||
| Part C - Primary Analysis |
|
The FETONET study was designed to have 3 parts. Part A evaluated the biodistribution, dosimetry and safety of [18F]FET-βAG-TOCA. Radiotracer uptake was assessed at multiple time points over 4 hours. An optimal imaging time point was determined. Part B utilised this time point within a larger cohort. Part C comprised a prospective non-inferiority study, analysing the [18F]FET-βAG-TOCA PET/CT data collected during Parts A & B, and comparing this to [Ga68]Ga-DOTA-peptide PET-CT imaging (SoC).
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Patients With Histologically-confirmed NET. | Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic [18F]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of [18F]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of [18F]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body [18F]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 & 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | To Determine the Biodistribution of [18F] Following Single I.V Administration of [18F]-FET-βAG-TOCA Injection in Patients With a Histological Diagnosis of NET. | Mean residence time (MRT) was used to characterise the biodistribution of [18F]-FET-βAG-TOCA throughout the body. Mean residence time is a pharmacokinetic/uptake parameter that describes the average length of time a radiotracer resides within the body, or a particular organ, before being eliminated. Understanding MRT helps researchers to determine how long a radiotracer remains in the system, which is crucial for drug dosing, therapeutic efficacy, and potential toxicity assessment. | The number of participants analysed differ within certain rows (breasts, ovaries, uterus and testes due to the anatomical differences between the participant groups. | Posted | Mean | Standard Deviation | Mean Residence Time (MBq-h/MBq) | Baseline (on day of scan over 4 hours) |
|
Safety data will be collected at baseline and after the administration of the radiotracer for up to 24 hours.
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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 | Part A | Patients with histologically-confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic [18F]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4 hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Rohini Sharma | Imperial College London | 0203 313 3720 | r.sharma@imperial.ac.uk |
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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 | Dec 12, 2016 | May 23, 2024 | 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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| OTHER |
| Invicro | OTHER |
| Newcastle University | OTHER |
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| [68Ga]Ga-DOTA-peptide PET/CT imaging performed within 6 months of the [18F]-FET-βAG-TOCA PET/CT scan. |
| Comparison of [18F]-FET-βAG-TOCA PET/CT Scan and Central Review (Nuclear Medicine and Radiology Physician Experts) of All Imaging Received. | The [18F]FET-βAG-TOCA and [68Ga]Ga-DOTA-peptide PET/CT scans were reviewed by independent imaging experts to obtain an objective inter-reader lesion detection rate. To avoid recall bias, the [18F]FET-βAG-TOCA and [68Ga]Ga-DOTA-peptide PET/CT scans for each subject were reviewed at less 4 weeks apart in random order Percentage of agreement, also known as percent agreement, is a simple method to measure inter-rater reliability (IRR), calculating the proportion of times raters agree without considering chance. It's calculated by dividing the number of agreements by the total number of ratings and multiplying by 100 | [68Ga]Ga-DOTA-peptide PET/CT imaging assessed within 6 months of the [18F]-FET-βAG-TOCA PET/CT scan. |
| Dubash S, Barwick TD, Kozlowski K, Rockall AG, Khan S, Khan S, Yusuf S, Lamarca A, Valle JW, Hubner RA, McNamara MG, Frilling A, Tan T, Wernig F, Todd J, Meeran K, Pratap B, Azeem S, Huiban M, Keat N, Lozano-Kuehne JP, Aboagye EO, Sharma R. Somatostatin Receptor Imaging with [18F]FET-betaAG-TOCA PET/CT and [68Ga]Ga-DOTA-Peptide PET/CT in Patients with Neuroendocrine Tumors: A Prospective, Phase 2 Comparative Study. J Nucl Med. 2024 Feb 8;65(3):416-22. doi: 10.2967/jnumed.123.266601. Online ahead of print. |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Part B: [18F]-FET-βAG-TOCA-PET/CT Compared With [68Ga]Ga-DOTA-peptide PET/CT in Patients With NET. | Patients with histologically confirmed neuroendocrine tumours (NET) underwent PET/CT imaging with both [18F]-FET-βAG-TOCA and [68Ga]Ga-peptide. The two PET/CT scans were performed within a 6-month time period. Whole-body static [18F]-FET-βAG-TOCA PET-CT imaging was conducted 50 minutes post-injection. The maximum dose of [18F]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part B of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of the [18F]-FET-βAG-TOCA (Maximum injected dose of 370MBq)
Total effective dose: 9 mSv In Part B of the FETONET study, one low-dose attenuation CT scan was performed per patient. Whereas, two low-dose attenuation CT scans were performed per patient in Part A. The total effective dose per patient was therefore lower in Part B. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Site of Primary Tumour | Count of Participants | Participants |
|
| Tumour Grade - Histological Confirmation | Histological confirmation of tumour grade. Grade 1 NETs consist of cells that look very similar to normal cells. Tumours are slow growing and less likely to spread - well differentiated tumours. Grade 2 NETs consist of cells that look less like normal cells and are more likely to grow and spread - moderately differentiated tumours. | Count of Participants | Participants |
|
Mean residence time (MBq.h/MBq) of [18F]-FET-βAG-TOCA within the organs of the male participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic [18F]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of [18F]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of [18F]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body [18F]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 & 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A. |
| OG001 | Part A: [18F]-FET-βAG-TOCA-PET/CT Performed in Female Patients With Histologically-confirmed NET. | Mean residence time (MBq.h/MBq) of [18F]-FET-βAG-TOCA within the organs of the female participants enrolled into Part A of the FETONET study. Patients with histologically confirmed neuroendocrine tumours (NET) enrolled into Part A of the FETONET study underwent whole-body dynamic [18F]-FET-βAG-TOCA PET/CT imaging at multiple time points over a 4-hour period, with sampling of venous bloods for radioactivity and radioactive metabolite quantification. The maximum dose of [18F]-FET-βAG-TOCA injected was 165MBq. Imaging Protocol for patients in Part A of the FETONET study: -2 minutes - Low dose attenuation CT. 0 minutes - Injection of [18F]-FET-βAG-TOCA (maximum of 165MBq) 0-242 - Dynamic whole body [18F]-FET-βAG-TOCA PET-CT (6 sweeps of the body). Following the fourth sweep, the patient had a 20 minutes break. The patient returned to the PET-CT scanner and had a second low-dose attenuation CT scan before completing PET/CT sweeps 5 & 6. Total effective dose: 12 mSv In Part A of the FETONET study, two low-dose attenuation CT scans were performed per patient. Whereas, only one low-dose attenuation CT scan was performed per patient in Part A. The total effective dose per patient was therefore higher in Part A. |
|
|
| Primary | To Calculate the Effective Dose (ED) of [18F]-FET-βAG-TOCA | Effective dose is an estimate of the overall risk of potential harm from exposure to ionising radiation. ED takes into account, the absorbed dose to all organs of the body, the relative harm level of the radiation and the sensitivities of each organ to radiation. ED may help in understanding the risk of potential long-term health effects from radiation exposure, such as the risk of developing cancer later in life. The unit of measure for ED is millisievert per megabecquerel (mSv/MBq), which refers to the effective dose (amount of radiation absorbed by the body) per unit of activity administered. | Effective dose (ED) of [18F]-FET-βAG-TOCA in patients with histologically confirmed NETs. | Posted | Mean | Standard Deviation | Effective Dose (mSv/MBq) | Baseline (on the day of the scan over 4 hours) |
|
|
|
| Primary | To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA | Standardised uptake value (SUV) is a semiquantitative measurement of radiotracer uptake in tissue. It is a ratio that compares the activity concentration in a specific region of interest to the activity concentration in the whole body. SUVmax is the highest value of the SUV measured within a region of interest. | The FETONET study was designed to have 3 parts. Part C comprised a prospective non-inferiority study, combining the [18F]FET-βAG-TOCA PET/CT data (collected at the optimal time point) for participants enrolled into Part A and Part B and compared this to standard of care [68Ga]Ga-DOTA-peptide PET/CT imaging. This trial design was a prospective decision for the purposes of efficiency. A total of 285 lesions were detected within the 45 patients analysed using this imaging modality. | Posted | Median | Full Range | SUVmax | Baseline (on the scan day over 4 hours) | Lesions | Lesions |
|
|
|
| Secondary | To Compare the Diagnostic Efficacy of [18F]-FET-βAG-TOCA PET/CT With Standard of Care Somatostatin Receptor Imaging in Patients With a Histological Diagnosis of NET. | To determine the clinical utility of [18F]-FET-βAG-TOCA-PET/CT compared with standard of care [68Ga]Ga-DOTA-peptide imaging. Standardised uptake value (SUV) is a semiquantitative measurement of radiotracer uptake in tissue. It is a ratio that compares the activity concentration in a specific region of interest to the activity concentration in the whole body. SUVmax is the highest value of the SUV measured within a region of interest. The median SUVmax of [18F]-FET-βAG-TOCA and [68Ga]-DOTA-peptide per anatomic region were calculated to determine diagnostic efficacy. Diagnostic efficacy is the ability of a test to correctly identify a disease or condition when it's present and correctly identify the absence of a disease when it's not present. | The FETONET study was designed to have 3 parts. Part C comprised a prospective non-inferiority study. [18F]FET-βAG-TOCA PET/CT data collected for patients enrolled into Parts A and B of the FETONET study were combined and compared to [68Ga]Ga-DOTA-peptide PET/CT (standard of care) imaging. This trial design was a prospective decision for the purposes of efficiency. A total of 285 lesions (45 patients) were detected using [18F]-FET-βAG-TOCA & [68Ga]Ga-DOTA-peptide PET/CT imaging. | Posted | Median | Full Range | Median Tumour Uptake (SUVmax) | [68Ga]Ga-DOTA-peptide PET/CT imaging performed within 6 months of the [18F]-FET-βAG-TOCA PET/CT scan. | Lesions | Lesions |
|
|
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| Secondary | Comparison of [18F]-FET-βAG-TOCA PET/CT Scan and Central Review (Nuclear Medicine and Radiology Physician Experts) of All Imaging Received. | The [18F]FET-βAG-TOCA and [68Ga]Ga-DOTA-peptide PET/CT scans were reviewed by independent imaging experts to obtain an objective inter-reader lesion detection rate. To avoid recall bias, the [18F]FET-βAG-TOCA and [68Ga]Ga-DOTA-peptide PET/CT scans for each subject were reviewed at less 4 weeks apart in random order Percentage of agreement, also known as percent agreement, is a simple method to measure inter-rater reliability (IRR), calculating the proportion of times raters agree without considering chance. It's calculated by dividing the number of agreements by the total number of ratings and multiplying by 100 | The FETONET study was designed to have 3 parts. Part C comprised a prospective non-inferiority study. [18F]FET-βAG-TOCA PET/CT data for the patients enrolled into Parts A and B of the FETONET study (45 patients) were compared to standard of care [68Ga]Ga-DOTA-peptide PET/CT imaging. This trial design was a prospective decision for the purposes of efficiency. All PET/CT scans analysed within Part C were reviewed by independent imaging experts to determine an inter-reader lesion detection rate. | Posted | Number | Percentage of Agreement | [68Ga]Ga-DOTA-peptide PET/CT imaging assessed within 6 months of the [18F]-FET-βAG-TOCA PET/CT scan. |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 2 |
| 9 |
| EG001 | Part B | Patients with histologically confirmed neuroendocrine tumours (NET) underwent PET/CT imaging with both [18F]-FET-βAG-TOCA and [68Ga]Ga-peptide. The two PET/CT scans were performed within a 6-month time period. Whole-body static [18F]-FET-βAG-TOCA PET-CT imaging was conducted 50 minutes post-injection. | 0 | 47 | 0 | 47 | 1 | 47 |
| Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
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| Altered Taste Sensation | General disorders | Systematic Assessment |
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Not provided
Not provided
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| D009380 | Neoplasms, Nerve Tissue |
| Lung |
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| Other |
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| Unknown |
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| Liver |
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| Bone |
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| Pancreas |
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| Abdomen/Pelvis |
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| Lymph Nodes |
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| Lung |
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| Liver |
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| Bone |
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| Pancreas |
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| Abdomen/Pelvis |
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| Lymph Nodes |
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| Lung |
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| Liver |
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| Pancreas |
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| Abdomen/Pelvis |
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| Bone |
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| Lymph Node |
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