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

An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Computed Tomography (procedure)
• Gallium Ga 68-DOTA-FAPI-04 (drug)
• Positron Emission Tomography (procedure)

Sponsor: University of Michigan Rogel Cancer Center · Participants: 30 · Started: Sep 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07132645

Locations in the U.S.

Conditions

• Neuroendocrine Tumors

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.