NCT06413355

FAPI-74 PET/CT in Adults With Fibrosis

Fibroblast Activating Protein (FAP) PET/CT in Adults With Fibrotic Conditions

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 15 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))

Conditions

• Fibrosis (Morphologic Abnormality)

Interventions

Type	Name	Description
DRUG	[F-18]-FAPI-74	A positron-emitting radiopharmaceutical that has been studied in animals for selective measurement of the in vivo expression of FAP with positron emission tomography (PET/CT).

Timeline

• Start date: 2024-07-16
• Primary completion: 2027-07-30
• Completion: 2027-07-30
• First posted: 2024-05-14
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study