NCT06413355 FAPI-74 PET/CT in Adults With Fibrosis
| NCT ID | NCT06413355 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Fibrosis (Morphologic Abnormality) |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-07-16 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2024-07-16 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Mark A Sellmyer, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06413355 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Fibrosis (Morphologic Abnormality). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06413355 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06413355 currently recruiting?
Yes, NCT06413355 is actively recruiting participants. Contact the research team at erinschu@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06413355 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06413355 clinical trial?
NCT06413355 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Mark A Sellmyer, MD, PhD at University of Pennsylvania. The trial plans to enroll 45 participants.