RecruitingEarly Phase 1

An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer

United States30 participantsStarted 2025-09-16

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)

Timeframe: Day 1

Pharmacokinetics of [68Ga] Ga-FAPI-04

Timeframe: Day 1

Trial details

NCT IDNCT07132645

SponsorUniversity of Michigan Rogel Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

View on ClinicalTrials.gov More Neuroendocrine Tumor trials