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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Undergo CT scan
Given IV
Undergo PET scan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGBiodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
Time frame: Day 1
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.
Time frame: Day 1
Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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