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

Not Applicable

Not yet recruiting

• Conditions: Neuroendocrine Tumor
• Interventions: Procedure: Computed Tomography; Drug: Gallium Ga 68-DOTA-FAPI-04; Procedure: Positron Emission Tomography

• Registration Number: NCT07132645
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-14
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-09-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Basic science ([68Ga] Ga-FAPI-04)	Computed Tomography	Patients receive \[68Ga\] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
Basic science ([68Ga] Ga-FAPI-04)	Gallium Ga 68-DOTA-FAPI-04	Patients receive \[68Ga\] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
Basic science ([68Ga] Ga-FAPI-04)	Positron Emission Tomography	Patients receive \[68Ga\] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.

Primary Outcome Measures

Name	Time	Method
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)	Day 1
Pharmacokinetics of [68Ga] Ga-FAPI-04	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Clinical diagnostic performance of [68Ga] Ga-FAPI-04	Day 1	When a comparison Ga-DOTATATE scan is available, we will look at the uptake in the tumor in the SOC image related to reference tissue and then compare the FAPI-04 uptake.
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	Will compare the difference in SUVmax uptake within each subject using a two-side, one-sample t-test.

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States