Neuroendocrine Tumors, NETNET-COMPARENCT07621146
A Comparison of [68Ga]DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies
An observational study of Neuroendocrine Tumors, NET and Pheochromocytoma/Paraganglioma, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of molecules called somatostatin receptors (SSTR) which requires specific PET scan tracers to sufficiently capture on images. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, NET, Pheochromocytoma/Paraganglioma, SSTR-expressing Tumors
- What is being tested?
- 68Ga-DOTATATE PET/CT and 18F-AmBF3-TATE PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: This will be a prospective, open-label trial in patients with suspected or proven SSTR positive tumors.
Who may be able to join
- Age ≥18 years
- Patients referred for and meeting institutional criteria for a [68Ga]DOTATATE PET/CT for the investigation of a known or suspected neuroendocrine malignancy (BC Cancer criteria APPENDIX A).
Who cannot join
- Pregnant and breast-feeding patients.
- Patients unwilling or unable to undergo a second PET/CT.
- Patients exceeding the safe weight limit of the scanner (204.5 kg) or who cannot fit through the PET/CT bore (70cm diameter).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6
Pavithraa Ravi, 6048776000 ext. 2818, pavithraa.ravi@bccancer.bc.ca
About this study
Official title: A Prospective and Head-to-head Comparison of [68Ga] Ga-DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies: NET-COMPARE Study
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of molecules called somatostatin receptors (SSTR) which requires specific PET scan tracers to sufficiently capture on images. The current standard of care tracer at BC Cancer for SSTRs on NETs is 68Ga-DOTATATE. This project seeks to identify if 18F-AmBF3-TATE (a tracer that has established safety from phase 1 trial results), is comparable in disease detection, no. of lesions identified, image quality, safety and overall accuracy, to 68Ga-DOTATATE.
- Conditions
- Neuroendocrine Tumors, NET, Pheochromocytoma/Paraganglioma, SSTR-expressing Tumors, Medullary Thyroid Carcinoma
- Being tested
- 68Ga-DOTATATE PET/CT, 18F-AmBF3-TATE PET/CT
- Medical subject headings
- Neuroendocrine Tumors, Pheochromocytoma, Paraganglioma, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATATE PET/CTDiagnostic test
Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the standard of care tracer 68Ga-DOTATATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
18F-AmBF3-TATE PET/CTDiagnostic test
Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the investigational tracer 18F-AmBF3-TATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT Diagnostic Imaging | Each subject will have two PET/CT scans, one using 68Ga-DOTATATE and the other using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 68Ga-DOTATATE is considered standard care and has been approved by Health Canada. Receives: Diagnostic Test: 68Ga-DOTATATE PET/CT; Diagnostic Test: 18F-AmBF3-TATE PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE
To assess the non-inferiority of [18F]AmBF3TATE compared to the standard-of-care [68Ga]DOTATATE
Measured: Periprocedural
Secondary outcomes (5)
Number of patients in whom one or more target lesions are detected by the core readers.
Number of patients in whom [18F]AmBF3TATE and [68Ga]DOTATATE detects disease.
Measured: within 2 weeks of the scan
Standard Uptake Values (SUV) for lesions detected
To assess uptake values (SUV) for tumour lesions (SUVmax, SUVpeak, tumour to background ratio for liver, blood, kidney and lung, contrast and signal to noise ratio).
Measured: within 2 weeks of the scan
CNR (contrast to noise ratio), TBR (tumor tissue to background tissue ratio), Tumor/blood; Tumor/Liver; Tumor/ kidney; tumor/lung, Likert scale for reader quality assessment
To assess image quality using semi-quantitative (contrast-to-noise and tumour-to-background) and subjective indices
Measured: within 2 weeks of the scan
Diagnostic confidence on a three-point scale (high, moderate and low), Fleiss' Kappa to measure inter-rater agreement
To assess reader confidence and inter-rater agreement
Measured: within 2 weeks of the scan
Frequency of adverse events (AE) and serious adverse events (SAE).
To compare the safety of both tracers
Measured: Immediately post-scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start30 Nov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Tumors, NETStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Alberts, MBBS MD PhD FEBNM, Principal investigator, BC Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621146
- Sponsor's protocol ID
- H26-00640
- Acronym
- NET-COMPARE
- Status last verified
- Oct 2026
- First submitted
- 11 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Head-to-head Comparison of [68Ga] Ga-DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies: NET-COMPARE Study
- ClinicalTrials.gov ID
- NCT07621146
- Acronym / sponsor ID
- NET-COMPARE / H26-00640
- Conditions
- Neuroendocrine Tumors, NET, Pheochromocytoma/Paraganglioma, SSTR-expressing Tumors, Medullary Thyroid Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of molecules called somatostatin receptors (SSTR) which requires specific PET scan tracers to sufficiently capture on images. The current standard of care tracer at BC Cancer for SSTRs on NETs is 68Ga-DOTATATE. This project seeks to identify if 18F-AmBF3-TATE (a tracer that has established safety from phase 1 trial results), is comparable in disease detection, no. of lesions identified, image quality, safety and overall accuracy, to 68Ga-DOTATATE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT Diagnostic Imaging | – | Diagnostic Test: 68Ga-DOTATATE PET/CT, Diagnostic Test: 18F-AmBF3-TATE PET/CTEach subject will have two PET/CT scans, one using 68Ga-DOTATATE and the other using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 68Ga-DOTATATE is considered standard care and has been approved by Health Canada. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a prospective, open-label trial in patients with suspected or proven SSTR positive tumors.
Key inclusion criteria (2 listed)
- Age ≥18 years
- Patients referred for and meeting institutional criteria for a [68Ga]DOTATATE PET/CT for the investigation of a known or suspected neuroendocrine malignancy (BC Cancer criteria APPENDIX A).
Key exclusion criteria (3 listed)
- Pregnant and breast-feeding patients.
- Patients unwilling or unable to undergo a second PET/CT.
- Patients exceeding the safe weight limit of the scanner (204.5 kg) or who cannot fit through the PET/CT bore (70cm diameter).
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 |
|---|---|---|
| 68Ga-DOTATATE PET/CTEach study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the standard of care tracer 68Ga-DOTATATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired. | Diagnostic test | PET/CT Diagnostic Imaging |
| 18F-AmBF3-TATE PET/CTEach study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the investigational tracer 18F-AmBF3-TATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired. | Diagnostic test | PET/CT Diagnostic Imaging |
Primary outcome
Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE
Time frame: Periprocedural
To assess the non-inferiority of [18F]AmBF3TATE compared to the standard-of-care [68Ga]DOTATATE
5 secondary outcomes
Number of patients in whom one or more target lesions are detected by the core readers.
Time frame: within 2 weeks of the scan
Standard Uptake Values (SUV) for lesions detected
Time frame: within 2 weeks of the scan
CNR (contrast to noise ratio), TBR (tumor tissue to background tissue ratio), Tumor/blood; Tumor/Liver; Tumor/ kidney; tumor/lung, Likert scale for reader quality assessment
Time frame: within 2 weeks of the scan
Diagnostic confidence on a three-point scale (high, moderate and low), Fleiss' Kappa to measure inter-rater agreement
Time frame: within 2 weeks of the scan
Frequency of adverse events (AE) and serious adverse events (SAE).
Time frame: Immediately post-scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Neuroendocrine Tumors, NET
RecruitingPhase 2
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Digestive System Neuroendocrine Tumor G2
Enrolling by invitationObservational study
Liver Transplantation Versus Conventional Medical Therapy for Low-Grade GEP-NET With Liver Metastases
Neuroendocrine Tumors
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
Active, not recruitingObservational study
Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and April 30, 2014
Neuroendocrine Tumors, NET
RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
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.
Ian Alberts, MBBS MD PhD FEBNM principal investigator
BC Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, NET and Pheochromocytoma/Paraganglioma, run by British Columbia Cancer Agency at 1 site in Canada.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Project Manager (604-675-8000 ext. 7649, MITclinicaltrials@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.