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

University of Michigan Rogel Cancer Center

Status and phase: Enrolling; Early Phase 1

Conditions: Neuroendocrine Tumor

Treatments: Drug: Gallium Ga 68-DOTA-FAPI-04; Procedure: Positron Emission Tomography; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT07132645

UMCC 2024.069

HUM00237403 (Other Identifier)

NCI-2025-04557 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Procedure: Computed Tomography

Procedure: Positron Emission Tomography

Drug: Gallium Ga 68-DOTA-FAPI-04