New PET scan aims to spot hidden scar tissue
NCT ID NCT06413355
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special PET/CT scan that uses a tracer called FAPI-74 to find fibrosis (scar-like tissue) in the body. It includes 45 adults with conditions like head and neck cancer or tuberculosis that can cause fibrosis. The goal is to see how well the scan shows fibrosis, which could help doctors better diagnose and monitor these diseases.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A glowing dye could expose hidden heart scarring
- Can a weekly injection calm heart inflammation in sarcoidosis?
- Can tumor genetics unlock gentler treatments for head and neck cancer?
- Can less radiation be safer for throat cancer?