A Comparison of [68Ga]DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies
NET-COMPARE
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
1 other identifier
observational
51
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 2, 2026
CompletedStudy Start
First participant enrolled
September 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
Study Completion
Last participant's last visit for all outcomes
March 1, 2028
June 2, 2026
May 1, 2026
6 months
May 11, 2026
May 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Periprocedural
Secondary Outcomes (5)
Number of patients in whom one or more target lesions are detected by the core readers.
within 2 weeks of the scan
Standard Uptake Values (SUV) for lesions detected
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
within 2 weeks of the scan
Diagnostic confidence on a three-point scale (high, moderate and low), Fleiss' Kappa to measure inter-rater agreement
within 2 weeks of the scan
Frequency of adverse events (AE) and serious adverse events (SAE).
Immediately post-scan
Study Arms (1)
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.
Interventions
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. The participant will rest in a comfortable chair for 60 minutes. After this 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.
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. The participant will rest in a comfortable chair for 60 minutes. After this 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.
Eligibility Criteria
This will be a prospective, open-label trial in patients with suspected or proven SSTR positive tumors.
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Alberts, MBBS MD PhD FEBNM
BC Cancer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2026
First Posted
June 2, 2026
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share