An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms
University of Michigan Rogel Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- ProcedureComputed Tomography
Undergo CT scan
- DrugGallium Ga 68-DOTA-FAPI-04
Given IV
- ProcedurePositron Emission Tomography
Undergo PET scan
Location
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan