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
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.
- 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