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RecruitingInterventionalEarly Phase 1

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

NCT ID: NCT07132645Sponsor: University of Michigan Rogel Cancer CenterLast updated: 2025-09-23

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.

Arms & interventions

  • ProcedureComputed Tomography

    Undergo CT scan

  • DrugGallium Ga 68-DOTA-FAPI-04

    Given IV

  • ProcedurePositron Emission Tomography

    Undergo PET scan

Outcome measures

Primary

  • 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

Secondary

  • 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

    Time frame: Day 1

  • Clinical diagnostic performance of [68Ga] Ga-FAPI-04

    Time frame: Day 1

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

Recruiting
Benjamin Viglianti · Contact
734-936-5385bviglia@med.umich.edu
Benjamin Viglianti · Principal Investigator