NCT06413355 · Abramson Cancer Center at Penn Medicine
FAPI-74 PET/CT in Adults With Fibrosis
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (by cohort) Head and Neck Cancer Cohort:
- Participants will be ≥ 21 years of age
- Diagnosis of oropharyngeal squamous cell carcinoma (OPSCC)
- Determined to be surgical candidates
- History of known or suspected fibrosis-inducing medical condition PTLD Cohort:
- Participants will be ≥ 21 years of age
- Diagnosed with microbiologically confirmed DS-pTB (culture or PCR positive)
- History of known or suspected fibrosis-inducing medical condition.
- Patient-reported completion of TB treatment within 2 years of enrollment. Cardiac Sarcoidosis Cohort:
- Participants will be ≥ 21 years of age
- FDG PET/CT scan consistent with metabolically active cardiac sarcoidosis
- Clinical suspicion of cardiac involvement defined as the presence of any of the following:
- High degree A-V nodal block
- Reduced left or right ventricular systolic fusion
- History of ventricular arrhythmias
- Unexplained syncope Exploratory Cohort:
- Participants will be ≥ 21 years of age
- 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:
- Diagnosed with TB that is resistant to rifampin per medical record review
- History of alternative pulmonary disease per medical record review or patient self-report
- Have been administered corticosteroids or any other systemic investigational agents within 3 months of screening per medical record review or patient self-report
- Have symptoms or signs suggestive of active TB at the time of pre-screening per patient self-report All Cohorts:
- Women of childbearing potential may not be pregnant or breast-feeding. A negative pregnancy test will be required before \[F-18\]-FAPI-74injection.
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- 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
- Treatment with a therapeutic agent targeting fibroblast activation protein (FAP) within 1 month prior to study enrollment.
Where
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 9, 2026 · Source of record for eligibility and locations