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

NCT07132645 | Recruiting Early Phase 1 DMC FDA Drug

• 3 other identifiers: UMCC 2024.069NCI-2025-04557HUM00237403
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)

  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.

  Day 1

Secondary Outcomes (3)

• Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors

  Day 1

• Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors

  Day 1

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

  Day 1

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Computed Tomography PROCEDURE

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

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

Gallium Ga 68-DOTA-FAPI-04 DRUG

Given IV

Also known as: 68Ga-DOTA-FAPI-04, 68Ga-FAPi-04, GALLIUM GA-68-DOTA-FAPI-04, Gallium-68-FAPi-04

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

Positron Emission Tomography PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Neuroendocrine Research Foundation: collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

68Ga-FAPI; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Benjamin Viglianti

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 20, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)