PET/CT imaging with [68Ga] Ga-FAPI-04 for people with high-grade neuroendocrine cancer
Official title: An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms
Run by University of Michigan Rogel Cancer Center · NCT07132645 · Data updated 2026-11-12
This will test if a PET/CT scan using [68Ga] Ga-FAPI-04 can find high-grade neuroendocrine cancer in adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | September 16, 2025 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT07132645 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with confirmed high-grade neuroendocrine tumors who meet imaging or pathology criteria (prior low 68Ga-DOTATATE uptake, Krenning score ≥ 3, or Ki-67 ≥ 20%), can lie flat for about an hour, and can give informed consent.
✕Probably not a fit
Pregnant or breastfeeding people, patients with recent surgical wounds that are still healing, or those whose tumors are already well visualized with standard imaging are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early Phase I trial gives adults with high-grade neuroendocrine tumors a small dose of the radiotracer [68Ga] Ga-FAPI-04 followed by PET/CT imaging to map tracer uptake in tumors and normal tissues. PET detects the radioactive tracer while CT provides detailed anatomic images, allowing comparison of tracer accumulation with organ and lesion anatomy. Eligible participants must meet tumor criteria such as prior low 68Ga-DOTATATE uptake, a Krenning score ≥ 3, or Ki-67 ≥ 20% and be able to lie flat for about 60 minutes during imaging. The study is focused on describing biodistribution and imaging characteristics rather than providing treatment.
Why it matters
Potential benefit: If successful, this imaging approach could better locate high-grade neuroendocrine tumors that don't show up well with conventional tracers, potentially improving staging and treatment planning.
How similar studies have gone: FAPI-based PET tracers have shown promising uptake across several cancer types in early studies, but their specific value for high-grade neuroendocrine tumors is still limited and under active investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s): * Previous low uptake of \[68Ga\] Ga-DOTATATE PET/CT scan OR * Krenning Score ≥ 3 OR * Ki67 index ≥ 20% * Able to lie flat for 60 minutes * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Pregnancy or lactation * Patient recently underwent surgery with wound healing
Where it's running
-
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: Benjamin Viglianti — University of Michigan Rogel Cancer Center
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.