Actively Recruiting
Fibroblast Activating Protein (FAP) PET/CT in Adults With Fibrotic Conditions
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-02-09
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Fibroblast Activating Protein (FAP) PET/CT imaging to detect fibrosis caused by various medical conditions where fibrosis is believed to lead to harmful effects and poor outcomes. This phase 1 basket protocol includes patients with fibrosis-inducing diseases such as cancer-associated fibrosis, post-infection, post-radiation, pre or post-transplant, and fibrosis affecting the heart, liver, kidneys, or lungs. The study aims to expand with additional imaging groups as needed to gather clinical data supporting the use of FAP-targeted therapies. Participants will receive an intravenous injection of approximately 6.0 to 8.0 mCi of the radiopharmaceutical [F-18]-FAPI-74, which binds to fibroblast activating protein and allows visualization via PET/CT scan from head to mid-thigh. Some participants may have a second PET/CT scan at a later time to observe changes in fibrosis naturally or in response to therapy. The study includes specific cohorts such as head and neck cancer, post tubercular lung disease, cardiac sarcoidosis, and an exploratory group. During the study, participants will undergo PET/CT imaging sessions to measure the distribution and uptake of [F-18]-FAPI-74 in tissues affected by fibrosis. Imaging results will be compared with clinical pathology and laboratory tests related to fibrosis. The study does not use imaging results to guide treatment decisions, which remain the responsibility of the treating physicians. The primary outcomes focus on PET/CT image analysis over three years. Participation requires informed consent and adherence to imaging procedures.
CONDITIONS
Brief Title
FAPI-74 PET/CT in Adults With Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 21 years of age or older
- Diagnosis or suspicion of fibrosis-inducing medical condition
- For head and neck cancer cohort: diagnosis of oropharyngeal squamous cell carcinoma and surgical candidacy
- For post tubercular lung disease cohort: microbiologically confirmed drug-sensitive pulmonary tuberculosis and completed TB treatment within 2 years
- For cardiac sarcoidosis cohort: FDG PET/CT consistent with active cardiac sarcoidosis and clinical suspicion of cardiac involvement
- Willingness to provide written informed consent and comply with study procedures
You will not qualify if you...
- For head and neck cancer cohort: not eligible for tissue resection
- For post tubercular lung disease cohort: rifampin-resistant TB, alternative pulmonary disease, recent corticosteroid or investigational agent use, or active TB symptoms
- Women of childbearing potential who are pregnant or breastfeeding
- Inability to tolerate imaging procedures
- Any medical condition that may compromise safety or participation
- Treatment with an agent targeting fibroblast activation protein within 1 month prior to enrollment
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 - Single imaging session with optional additional scan at clinically relevant time points
Participants undergo PET/CT imaging with [F-18]-FAPI-74 to evaluate the presence and distribution of fibrosis in affected tissues and organs.
1 PET/CT imaging visit; an optional second imaging visit may occur depending on clinical needs
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
E
Erin Schubert
M
Mary Hansbury
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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