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.
Age ≥ 18 years old
Previous low uptake of [68Ga] Ga-DOTATATE PET/CT scan OR
Krenning Score ≥ 3 OR
Ki67 index ≥ 20%
Pregnancy or lactation
Patient recently underwent surgery with wound healing
Single group
Computed Tomography
Procedure/SurgeryUndergo CT scan
Gallium Ga 68-DOTA-FAPI-04
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
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.
Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors
Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors
Will compare the difference in SUVmax uptake within each subject using a two-side, one-sample t-test.
Clinical diagnostic performance of [68Ga] Ga-FAPI-04
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.
Click on the lead sponsor to view all of their trials.
University of Michigan Rogel Cancer Center
Lead sponsor
Neuroendocrine Research Foundation
Collaborator
