Recruiting
Early Phase 1

Ga-FAPI-04

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07132645

Conditions

Neuroendocrine Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Gallium Ga 68-DOTA-FAPI-04

Positron Emission Tomography

Study Details

Brief 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.

Conditions

Neuroendocrine Tumor

Study ID

NCT07132645

Start date

Sep 16, 2025

Status verified date

Jul, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Basic science ([68Ga] Ga-FAPI-04)

Patients receive \[68Ga\] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.

Interventions

Computed Tomography

Undergo CT scan

Gallium Ga 68-DOTA-FAPI-04

Given IV

Positron Emission Tomography

Undergo PET scan

Primary outcome measure

  • Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04) [ Time Frame: Day 1 ]
  • Pharmacokinetics of [68Ga] Ga-FAPI-04 [ Time Frame: Day 1 ]

Central Contacts and Locations

Locations

University of Michigan Comprehensive Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Benjamin Viglianti

734-936-5385bviglia@med.umich.edu

Principal Investigator:

Benjamin Viglianti

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-07-31.