Neuroendocrine TumorsPhase 1/2FETONETNCT06456723
Evaluation of [18F]Fluoroethyl Triazole Labelled [Tyr3]-Octreotate Analogues for the Imaging of Neuroendocrine Tumours.
A Phase 1/2 study testing [18F]-FET-βAG-TOCA in people with Neuroendocrine Tumors, run by Imperial College London.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- [18F]-FET-βAG-TOCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 14 May 2014to 17 Oct 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age ≥ 18 years
- Histological diagnosis of NET of any site, except where ENETS criteria does not mandate histology for confirmation of diagnosis or patients who have a positive 68Gallium-peptide scan in whom NET diagnosis is pre-operatively definitive.
- Locally advanced or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of <2 (appendix A).
- Life expectancy > 3 months.
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- Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥10mm using conventional techniques.
- Somatostatin receptor imaging within 6 months. (if patient does not have somatostatin receptor imaging they may also be included provided they have measurable disease (≥10mm) on conventional imaging.
- Adequate organ system function as defined within Table 1.
Who cannot join
- Patients received chemotherapy within 3 weeks of study.
- Patients received radiotherapy within 4 weeks of study.
- Active uncontrolled infections, gastrointestinal disease, haemolysis or any serious co-existing medical illness.
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Pregnant or lactating women.
- Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study.
- Presence of any underlying medical conditions which in the investigators opinion would make the patients unsuitable for treatment.
- Patient not expected to be able to tolerate the scanning sessions.
About this study
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.
Read the detailed description
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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- [18F]-FET-βAG-TOCA
- Keywords
- Positron Emission Tomography
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-FET-βAG-TOCADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [18F]-FET-βAG-TOCA |
| 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. Receives: Drug: [18F]-FET-βAG-TOCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (on the scan day over 4 hours)
Secondary outcomes (2)
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.
Measured: [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
Measured: [68Ga]Ga-DOTA-peptide PET/CT imaging assessed within 6 months of the [18F]-FET-βAG-TOCA PET/CT scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start14 May 2014
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Royal Marsden NHS Foundation Trust, University of Manchester, The Christie NHS Foundation Trust, Invicro, Newcastle University
- Responsible party
- Sponsor
- Investigators
- Rohini Sharma, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456723
- Sponsor's protocol ID
- 13HH0807
- Acronym
- FETONET
- Status last verified
- Apr 2025
- First submitted
- 28 May 2024
- Last updated
- 1 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
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.
PubMed 27173162Dubash 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.
PubMed 38331457
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [18F]Fluoroethyl Triazole Labelled [Tyr3]-Octreotate Analogues for the Imaging of Neuroendocrine Tumours.
- ClinicalTrials.gov ID
- NCT06456723
- Acronym / sponsor ID
- FETONET / 13HH0807
- Conditions
- Neuroendocrine Tumors
- Keywords
- Positron Emission Tomography
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Royal Marsden NHS Foundation Trust, University of Manchester, The Christie NHS Foundation Trust, Invicro, Newcastle University
- Study start
- 14 May 2014 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Posted 1 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: [18F]-FET-βAG-TOCA-PET/CT performed in patients with histologically-confirmed NET. | Experimental | Drug: [18F]-FET-βAG-TOCAPatients 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 | Drug: [18F]-FET-βAG-TOCAPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent
- Age ≥ 18 years
- Histological diagnosis of NET of any site, except where ENETS criteria does not mandate histology for confirmation of diagnosis or patients who have a positive 68Gallium-peptide scan in whom NET diagnosis is pre-operatively definitive.
- Locally advanced or metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of <2 (appendix A).
Key exclusion criteria (8 listed)
- Patients received chemotherapy within 3 weeks of study.
- Patients received radiotherapy within 4 weeks of study.
- Active uncontrolled infections, gastrointestinal disease, haemolysis or any serious co-existing medical illness.
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-FET-βAG-TOCASingle 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. | Drug | Part A: [18F]-FET-βAG-TOCA-PET/CT performed in patients with histologically-confirmed NET., Part B: [18F]FET-βAG-TOCA PET/CT compared with [68Ga]Ga-DOTA-peptide PET/CT in patients with NET. |
Primary outcome
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.
Time frame: Baseline (on day of scan over 4 hours)
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.
To Calculate the Effective Dose (ED) of [18F]-FET-βAG-TOCA
Time frame: Baseline (on the day of the scan over 4 hours)
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.
To Assess Tumoural Uptake of [18F]-FET-βAG-TOCA
Time frame: Baseline (on the scan day over 4 hours)
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.
2 secondary outcomes
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.
Time frame: [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.
Time frame: [68Ga]Ga-DOTA-peptide PET/CT imaging assessed within 6 months of the [18F]-FET-βAG-TOCA PET/CT scan.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27173162Dubash 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.
- Results publication: PubMed 38331457Dubash 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohini Sharma study chair
Imperial College London
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [18F]-FET-βAG-TOCA in people with Neuroendocrine Tumors, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline (on day of scan over 4 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456723, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.