Imaging fibrosis in adults using FAPI-74 PET/CT

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

This study is testing a new imaging method to see if a special scan can help find fibrosis in adults with different health conditions.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Abramson Cancer Center at Penn Medicine (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06413355 on ClinicalTrials.gov

What this trial studies

This study evaluates the use of Fibroblast Activating Protein (FAP) PET/CT imaging to detect fibrosis in adults with various medical conditions known to cause tissue fibrosis. Participants will receive an injection of [F-18]-FAPI-74 followed by a PET/CT scan to assess the distribution of FAP in affected organs. The study aims to gather data on the presence of fibrosis and its implications for patient prognosis, although treatment decisions will remain with the treating physicians based on clinical criteria. The study includes multiple cohorts, such as those with head and neck cancer, post-transplant lymphoproliferative disorder, and cardiac sarcoidosis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21 and older with known or suspected fibrosis-inducing medical conditions such as cancer, post-infection, or cardiac issues.

Not a fit: Patients without a clinical suspicion of fibrotic disease or those under 21 years of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this imaging technique could improve the diagnosis and understanding of fibrosis-related conditions, leading to better patient management.

How similar studies have performed: While the use of PET imaging in fibrosis is emerging, this specific approach with FAPI-74 is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria (by cohort)

Head and Neck Cancer Cohort:

1. Participants will be ≥ 21 years of age
2. Diagnosis of oropharyngeal squamous cell carcinoma (OPSCC)
3. Determined to be surgical candidates
4. History of known or suspected fibrosis-inducing medical condition

PTLD Cohort:

1. Participants will be ≥ 21 years of age
2. Diagnosed with microbiologically confirmed DS-pTB (culture or PCR positive)
3. History of known or suspected fibrosis-inducing medical condition.
4. Patient-reported completion of TB treatment within 2 years of enrollment.

Cardiac Sarcoidosis Cohort:

1. Participants will be ≥ 21 years of age
2. FDG PET/CT scan consistent with metabolically active cardiac sarcoidosis
3. Clinical suspicion of cardiac involvement defined as the presence of any of the following:

   1. High degree A-V nodal block
   2. Reduced left or right ventricular systolic fusion
   3. History of ventricular arrhythmias
   4. Unexplained syncope

Exploratory Cohort:

1. Participants will be ≥ 21 years of age
2. History of known or suspected fibrosis-inducing medical condition.

All Cohorts:

1\. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria (by cohort)

Head and Neck Cancer Cohort:

1\. Patient is not eligible for tissue resection

PTLD Cohort:

1. Diagnosed with TB that is resistant to rifampin per medical record review
2. History of alternative pulmonary disease per medical record review or patient self-report
3. Have been administered corticosteroids or any other systemic investigational agents within 3 months of screening per medical record review or patient self-report
4. Have symptoms or signs suggestive of active TB at the time of pre-screening per patient self-report

All Cohorts:

1. Women of childbearing potential may not be pregnant or breast-feeding. A negative pregnancy test will be required before \[F-18\]-FAPI-74injection.
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
3. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
4. Treatment with a therapeutic agent targeting fibroblast activation protein (FAP) within 1 month prior to study enrollment.

Where this trial is running

Philadelphia, Pennsylvania

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Mark A Sellmyer, MD, PhD — University of Pennsylvania
• Study coordinator: Erin Schubert

Conditions Fibrosis