An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan Rogel Cancer Center
- Study ID
- NCT07132645
- Phase
- EARLY_PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Computed Tomography — PROCEDUREUndergo CT scan
- Gallium Ga 68-DOTA-FAPI-04 — DRUGGiven IV
- Positron Emission Tomography — PROCEDUREUndergo PET scan
Study Details
This early phase I trial determines where and to what degree the tracer \[68Ga\] Ga-FAPI-04 accumulates in normal and cancer tissues in patients with high grade neuroendocrine cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research \[68Ga\] Ga-FAPI-04. Because some cancers take up \[68Ga\] Ga-FAPI-04, it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.
Key Dates
- Start date
- Sep 16, 2025
- Status verified
- Sep 2025
- Primary completion
- Sep 1, 2027
- Completion
- Sep 1, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Basic science ([68Ga] Ga-FAPI-04)Patients receive \[68Ga\] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
Primary Outcome Measure
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04) [ Time Frame: Day 1 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | Benjamin Viglianti (PRINCIPAL_INVESTIGATOR) |
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