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An Exploratory Study of [68Ga]Ga-fibroblast activation protein inhibitor 4 ([68Ga]Ga-FAPI-04) in patients with high-grade Neuroendocrine neoplasms

Primary Investigator
Viglianti, Benjamin
Status
OPEN TO ACCRUAL
Phase
Early Phase I
NCT Number
NCT07132645
UM Number
2024.069
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Head, Neck, and Endocrine Malignancies
ID (Protocol)
57482
Secondary Protocol No
HUM00237403
Scope
Unspecified
Sponsor Type
Institutional
Disease Site
Other Endocrine System
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: 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