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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
University of Michigan Comprehensive Cancer Center
RECRUITING
Ann Arbor
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Neuroendocrine Research Foundation
Leads: University of Michigan Rogel Cancer Center

This content was sourced from clinicaltrials.gov