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Clinical Trials in Canada / NCT07621146
Starting soon Observational

A Comparison of [68Ga]DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies

NCT07621146 · tracked via the Priya Life Science Canada tracker
Sponsor
British Columbia Cancer Agency
Phase
Observational
Started
2026-09-15
Last updated
2026-06-02

Condition(s) studied

Neuroendocrine Tumors, NETPheochromocytoma/ParagangliomaSSTR-expressing TumorsMedullary Thyroid Carcinoma

Investigational drug(s) / intervention(s)

68Ga-DOTATATE PET/CT18F-AmBF3-TATE PET/CT

68Ga-DOTATATE PET/CT: 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.

18F-AmBF3-TATE PET/CT: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
BC Cancer Vancouver Vancouver British Columbia

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Other trials for the same condition

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) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07621146 on ClinicalTrials.gov ↗ ← All trials in Canada