An Early Phase 1 interventional study of Computed Tomography and Gallium Ga 68-DOTA-FAPI-04 in Neuroendocrine Tumor, sponsored by University of Michigan Rogel Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by University of Michigan Rogel Cancer Center · Early Phase 1, Interventional, and Basic science
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.
Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):
Exclusion Criteria:
Patients receive \[68Ga\] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
Procedure: Computed Tomography · Drug: Gallium Ga 68-DOTA-FAPI-04 · Procedure: Positron Emission Tomography
Undergo CT scan
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography
Given IV
Also known as: 68Ga-DOTA-FAPI-04, 68Ga-FAPi-04, GALLIUM GA-68-DOTA-FAPI-04, Gallium-68-FAPi-04
Undergo PET scan
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
Time frame: Day 1
Pharmacokinetics of [68Ga] Ga-FAPI-04
We will monitor/measure the amount of Ga-FAPI-04 seen within different tissue in patients that have neuroendocrine tumors. We will specifically measure the ratio of uptake in the tumors in comparison to reference tissues such as liver or muscle.
Time frame: Day 1
Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors
Time frame: Day 1
Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors
Will compare the difference in SUVmax uptake within each subject using a two-side, one-sample t-test.
Time frame: Day 1
Clinical diagnostic performance of [68Ga] Ga-FAPI-04
When a comparison Ga-DOTATATE scan is available, we will look at the uptake in the tumor in the SOC image related to reference tissue and then compare the FAPI-04 uptake.
Time frame: Day 1
Plan to share: Undecided
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University of Michigan Rogel Cancer Center