FAPI-74 PET/CT in Adults With Fibrosis
- Conditions
- Fibrosis (Morphologic Abnormality)
- Interventions
- Drug: [F-18]-FAPI-74
- Registration Number
- NCT06413355
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
This protocol is intended as a basket protocol designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/CT in imaging the presence of fibrosis caused by a variety of medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis.
- Detailed Description
A study to evaluate subjects with fibrosis-inducing medical conditions that are known or suspected to cause tissue fibrosis (e.g. cancer-associated, post-infection, post-radiation, pre or post-transplant, cardiac, liver, kidney or pulmonary fibrosis). This protocol is intended to expand as needed with imaging arms designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/ CT in imaging the presence fibrosis caused by medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis.
\[18F\]-FAPI-74 is a positron emitting radiolabeled FAP inhibitor that will be used with a positron emission tomography/computed tomography (PET/CT) scan that will be completed in each subject who has a clinical suspicion of fibrotic disease.
PET/CT imaging will be used to evaluate the distribution of fibroblast activating protein (FAP) in major organs and other tissues affected with fibrotic diseases or conditions. This is an observational study in that \[F-18\]-FAPI-74 PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \[F-18\]-FAPI-74 PET/CT results, any medical or treatment decisions related to their underlying clinical diagnosis will be made by the treating physicians based upon clinical criteria.
After injection of \[F-18\]-FAPI-74, patients will undergo a vertex to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of approximately 8.0 mCi (expected range of doses is expected to be 6.0-8.0 mCi) of \[F-18\]-FAPI-74 intravenously. Data will be collected to evaluate uptake of \[F-18\]-FAPI-74 in sites of suspected fibrosis and in major organs.
An optional second PET/CT using \[F-18\]-FAPI-74 can be considered at the request of the investigators at any clinically relevant time point for the H\&N, Exploratory and Cardiac Sarcoidosis cohorts. This second scan may be used to quantify the changes in fibrosis over time as part of the natural progression of the fibrotic condition, or to observe changes in \[F-18\]-FAPI-74 uptake in response to therapeutic interventions.
Imaging cohorts include:
Head and neck cancer (up to 15 patients) Post tubercular lung disease (PTLD, up to 10 patients) Cardiac Sarcoidosis (up to 10 patients) Exploratory Cohort (Pilot studies for generating clinical data to support use of the radiotracer for FAP targeted therapies, up to 10 patients)
Uptake of \[F-18\]-FAPI-74 may be compared to other clinical pathology or lab results related to the presence of fibrosis (e.g. tissue sequencing, genomics, immunohistochemistry, ELISA, and similar assays))
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FAPI-74 PET/CT Scan [F-18]-FAPI-74 Head and neck cancer (up to 15 subjects), post tubercular lung disease (PTLD, up to 10 subjects), Cardiac Sarcoidosis and Exploratory (up to 10 subjects each) with fibrosis-inducing medical conditions that are known or suspected to cause tissue fibrosis (e.g. cancer-associated, postinfection, post-radiation, pre/post-transplant, cardiac, liver, kidney or pulmonary fibrosis).
- Primary Outcome Measures
Name Time Method Overall FAPI-74 PET/CT Image Analysis 3 years The overall quality of the generated images will be evaluated. Initial imaging of the vertex to mid-thigh will be used to investigate regional tracer uptake in suspected sites of fibrosis and normal tissues for this novel radiotracer. Uptake and retention of \[F-18\]-FAPI-74 in known or suspected sites of fibrotic disease will be evaluated visually by trained radiology readers, the principal investigator, or designee. A number of analysis methods may be tested to identify the optimal method for analyses for future studies with this radiotracer. \[F-18\]-FAPI-74 PET/CT scans will be interpreted both qualitatively and quantitatively.
Head and Neck Cancer FAPI-74 PET/CT Image Analysis 3 years \[18F\]-FAPi74 PET/CT data: Areas of uptake in tumors and healthy tissue will be measured by SUVmax and semiquantitative analysis will be conducted. In each case, lesion uptake will be marked as low, medium, and high avidity. Each lesion and lymph node will be separately measured and quantified. Measurements will be made by Dr. Sellmyer and co-Investigators (n=3).
PTLD FAPI-74 PET/CT Image Analysis 3 years Quantitative interpretation of FAP expression, will be recorded as a Standardized Uptake Value (SUV). Max, mean, and peak SUV values will be recorded for a region-of-interest encompassing a single primary lesion.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States