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

NCT07621146 — Not yet recruiting, 60 participants, British Columbia Cancer Agency

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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

Registry	NCT07621146, acronym NET-COMPARE
Status	Not yet recruiting
Study type	Observational
Enrollment	60 (Estimated)
Sponsor	British Columbia Cancer Agency (Other)
Conditions	Neuroendocrine Tumors, NET, Pheochromocytoma/Paraganglioma, SSTR-expressing Tumors, Medullary Thyroid Carcinoma
Interventions	68Ga-DOTATATE PET/CT, 18F-AmBF3-TATE PET/CT (Diagnostic test)
Dates	start 2026-11-30 (estimated), primary completion 2027-06-01 (estimated), completion 2028-03-01 (estimated), first posted 2026-06-02, last updated 2026-10-06
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
PET/CT Diagnostic Imaging		Diagnostic Test: 68Ga-DOTATATE PET/CT; Diagnostic Test: 18F-AmBF3-TATE PET/CT	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.

68Ga-DOTATATE PET/CT (Diagnostic 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/CT (Diagnostic 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.

+Outcome measures

Primary outcomes

Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE [Periprocedural]: To assess the non-inferiority of \[18F\]AmBF3TATE compared to the standard-of-care \[68Ga\]DOTATATE

Secondary outcomes

Number of patients in whom one or more target lesions are detected by the core readers. [within 2 weeks of the scan]: Number of patients in whom \[18F\]AmBF3TATE and \[68Ga\]DOTATATE detects disease.
Standard Uptake Values (SUV) for lesions detected [within 2 weeks of the scan]: 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).
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]: To assess image quality using semi-quantitative (contrast-to-noise and tumour-to-background) and subjective indices
Diagnostic confidence on a three-point scale (high, moderate and low), Fleiss' Kappa to measure inter-rater agreement [within 2 weeks of the scan]: To assess reader confidence and inter-rater agreement
Frequency of adverse events (AE) and serious adverse events (SAE). [Immediately post-scan]: To compare the safety of both tracers

+Eligibility

Sex: All, ages: 18 Years to any

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).

+Locations (1)

Facility	City	Country	Status
BC Cancer Vancouver	Vancouver, British Columbia	Canada

+Investigators

Ian Alberts, MBBS MD PhD FEBNM, Principal investigator, BC Cancer