Actively Recruiting
An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms
Led by University of Michigan Rogel Cancer Center · Updated on 2025-09-23
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan Rogel Cancer Center
Lead Sponsor
N
Neuroendocrine Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the accumulation and distribution of an investigational tracer called [68Ga] Ga-FAPI-04 in patients with high-grade neuroendocrine cancer. This early phase I trial aims to determine where and how much this tracer collects in both normal and cancerous tissues using advanced imaging techniques. The study utilizes PET/CT scans, where PET detects the radioactive tracer and CT provides detailed images of organs and any inflammation. Participants will receive an intravenous injection of [68Ga] Ga-FAPI-04, followed by a PET/CT scan approximately one hour later lasting about 25 minutes. The trial focuses on exploring the tracer's biodistribution, pharmacokinetics, and retention in tumors to assess its potential for clinical diagnostic performance. This is a single intervention study without masking or blinding. During the study, participants will undergo PET and CT scans to evaluate tracer uptake and distribution. Researchers will measure biodistribution, pharmacokinetics, tumor tissue concentrations, and standardized uptake values on the day of the scan. The total participation involves preparation for and completion of the scan and monitoring on the same day. Safety and diagnostic data will be collected to understand how this imaging agent behaves in the body.
CONDITIONS
Brief Title
An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Current diagnosis of neuroendocrine tumor with high-grade presentation
- Previous low uptake on [68Ga] Ga-DOTATATE PET/CT scan or Krenning Score 3 or higher or Ki67 index 20% or greater
- Able to lie flat for 60 minutes
- Willing and able to provide written informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Recent surgery with ongoing wound healing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an intravenous injection of [68Ga] Ga-FAPI-04 followed 1 hour later by a PET/CT scan lasting approximately 25 minutes to image high-grade neuroendocrine cancer.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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