Neuroendocrine Tumor
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo CT scan
DRUGGallium Ga 68-DOTA-FAPI-04
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET scan
Sponsors
University of Michigan Rogel Cancer Center
Neuroendocrine Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Viglianti
University of Michigan Rogel Cancer Center
Outcome results
None listed