Investigating [68Ga]Ga-FAPI-04 PET/CT for High-Grade Neuroendocrine Cancer

This study is testing an investigational scan called [68Ga]Ga-FAPI-04 PET/CT for people with high-grade neuroendocrine cancer. Researchers want to see where the imaging agent, Gallium Ga 68-DOTA-FAPI-04, goes in the body and how it moves through the system. This helps them understand if it can effectively highlight cancer cells. You might be able to join if you are 18 or older, have a high-grade neuroendocrine tumor, and can lie flat for 60 minutes. The study aims to enroll 30 participants. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is an early phase trial, meaning it's focused on understanding how the investigational scan works in the body.
What's involved
You would undergo a CT scan and a PET scan, which involves receiving Gallium Ga 68-DOTA-FAPI-04 intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
Your biodistribution and pharmacokinetics (how the drug moves through your body) will be measured on Day 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07132645

An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer

Recruiting
EARLY_PHASE1Ages 18+InterventionalBasic science
University of Michigan Rogel Cancer Center
~30 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Computed TomographyGallium Ga 68-DOTA-FAPI-04Positron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
Measured over Day 1
+1 more outcome measured
Neuroendocrine Tumor
1 sites across 1 states
Michigan1
  • Benjamin Viglianti · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

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Eligibility criteria

Inclusion

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

Pregnancy or lactation
Patient recently underwent surgery with wound healing
  • Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)Day 1
  • Pharmacokinetics of [68Ga] Ga-FAPI-04Day 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.