Recruiting
Phase 1

FAPI-74

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06413355

Conditions

Fibrosis (Morphologic Abnormality)

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

[F-18]-FAPI-74

Study Details

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.

Conditions

Fibrosis (Morphologic Abnormality)

Study ID

NCT06413355

Start date

Jul 16, 2024

Status verified date

Feb, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: FAPI-74 PET/CT Scan

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).

Interventions

[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).

Primary outcome measure

  • Overall FAPI-74 PET/CT Image Analysis [ Time Frame: 3 years ]
  • Head and Neck Cancer FAPI-74 PET/CT Image Analysis [ Time Frame: 3 years ]
  • PTLD FAPI-74 PET/CT Image Analysis [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Mark A Sellmyer, MD, PhD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-02-09.