RecruitingEarly Phase 1NCT07132645

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


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

30 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria2

  • Pregnancy or lactation
  • Patient recently underwent surgery with wound healing

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Interventions

PROCEDUREComputed Tomography

Undergo CT scan

DRUGGallium Ga 68-DOTA-FAPI-04

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET scan


Locations(1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

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NCT07132645


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