Fibrosis (Morphologic Abnormality)Phase 1NCT06413355
FAPI-74 PET/CT in Adults With Fibrosis
A Phase 1 study testing [F-18]-FAPI-74 in people with Fibrosis (Morphologic Abnormality), run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fibrosis (Morphologic Abnormality)
- What is being tested?
- [F-18]-FAPI-74
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 30 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 23Show fewer
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Erin Schubert, 215-573-6569, erinshu@pennmedicine.upenn.edu
Mark A Sellymer, MD, PhD, mark.sellymer@pennmedicine.upenn.edu
About this study
Official title: Fibroblast Activating Protein (FAP) PET/CT in Adults With Fibrotic Conditions
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.
Read the detailed description
A study to evaluate subjects with fibrosis-inducing medical conditions that are known or suspected to cause tissue fibrosis (e.g. cancer-associated, post-infection, post-radiation, pre or post-transplant, cardiac, liver, kidney or pulmonary fibrosis). This protocol is intended to expand as needed with imaging arms designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/ CT in imaging the presence fibrosis caused by medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis.
[18F]-FAPI-74 is a positron emitting radiolabeled FAP inhibitor that will be used with a positron emission tomography/computed tomography (PET/CT) scan that will be completed in each subject who has a clinical suspicion of fibrotic disease.
PET/CT imaging will be used to evaluate the distribution of fibroblast activating protein (FAP) in major organs and other tissues affected with fibrotic diseases or conditions. This is an observational study in that [F-18]-FAPI-74 PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [F-18]-FAPI-74 PET/CT results, any medical or treatment decisions related to their underlying clinical diagnosis will be made by the treating physicians based upon clinical criteria.
After injection of [F-18]-FAPI-74, patients will undergo a vertex to mid-thigh scan, starting at approximately 15 minutes post injection. PET/CT imaging sessions will include an injection of approximately 8.0 mCi (expected range of doses is expected to be 6.0-8.0 mCi) of [F-18]-FAPI-74 intravenously. Data will be collected to evaluate uptake of [F-18]-FAPI-74 in sites of suspected fibrosis and in major organs.
An optional second PET/CT using [F-18]-FAPI-74 can be considered at the request of the investigators at any clinically relevant time point for the H\&N, Exploratory and Cardiac Sarcoidosis cohorts. This second scan may be used to quantify the changes in fibrosis over time as part of the natural progression of the fibrotic condition, or to observe changes in [F-18]-FAPI-74 uptake in response to therapeutic interventions.
Imaging cohorts include:
Head and neck cancer (up to 15 patients) Post tubercular lung disease (PTLD, up to 10 patients) Cardiac Sarcoidosis (up to 10 patients) Exploratory Cohort (Pilot studies for generating clinical data to support use of the radiotracer for FAP targeted therapies, up to 10 patients)
Uptake of [F-18]-FAPI-74 may be compared to other clinical pathology or lab results related to the presence of fibrosis (e.g. tissue sequencing, genomics, immunohistochemistry, ELISA, and similar assays))
- Conditions
- Fibrosis (Morphologic Abnormality)
- Being tested
- [F-18]-FAPI-74
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]-FAPI-74Drug
Also called [18F] aluminium fluorine ((S)-2,2'(7- (2-(4-(3-(4-(2-(2- cyanopyrrolidin-1-yl)-2 oxoethylcarbamoyl)quinolin-6-yloxy) propyl)piperazin-1-yl)-2-oxoethyl)-1,4,7- triazonane-1,4-diyl)diacetic acid
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).
| Study group | Role | What they receive |
|---|---|---|
| FAPI-74 PET/CT Scan | Experimental | 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). Receives: Drug: [F-18]-FAPI-74 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall FAPI-74 PET/CT Image Analysis
The overall quality of the generated images will be evaluated. Initial imaging of the vertex to mid-thigh will be used to investigate regional tracer uptake in suspected sites of fibrosis and normal tissues for this novel radiotracer. Uptake and retention of [F-18]-FAPI-74 in known or suspected sites of fibrotic disease will be evaluated visually by trained radiology readers, the principal investigator, or designee. A number of analysis methods may be tested to identify the optimal method for analyses for future studies with this radiotracer. [F-18]-FAPI-74 PET/CT scans will be interpreted both qualitatively and quantitatively.
Measured: 3 years
Head and Neck Cancer FAPI-74 PET/CT Image Analysis
[18F]-FAPi74 PET/CT data: Areas of uptake in tumors and healthy tissue will be measured by SUVmax and semiquantitative analysis will be conducted. In each case, lesion uptake will be marked as low, medium, and high avidity. Each lesion and lymph node will be separately measured and quantified. Measurements will be made by Dr. Sellmyer and co-Investigators (n=3).
Measured: 3 years
PTLD FAPI-74 PET/CT Image Analysis
Quantitative interpretation of FAP expression, will be recorded as a Standardized Uptake Value (SUV). Max, mean, and peak SUV values will be recorded for a region-of-interest encompassing a single primary lesion.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start16 Jul 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrosis (Morphologic Abnormality)Studies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Sellmyer, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413355
- Sponsor's protocol ID
- 19923
- Other IDs
- 853610
- Status last verified
- Feb 2026
- First submitted
- 9 May 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroblast Activating Protein (FAP) PET/CT in Adults With Fibrotic Conditions
- ClinicalTrials.gov ID
- NCT06413355
- Acronym / sponsor ID
- 19923
- Conditions
- Fibrosis (Morphologic Abnormality)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A study to evaluate subjects with fibrosis-inducing medical conditions that are known or suspected to cause tissue fibrosis (e.g. cancer-associated, post-infection, post-radiation, pre or post-transplant, cardiac, liver, kidney or pulmonary fibrosis). This protocol is intended to expand as needed with imaging arms designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/ CT in imaging the presence fibrosis caused by medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis.
[18F]-FAPI-74 is a positron emitting radiolabeled FAP inhibitor that will be used with a positron emission tomography/computed tomography (PET/CT) scan that will be completed in each subject who has a clinical suspicion of fibrotic disease.
PET/CT imaging will be used to evaluate the distribution of fibroblast activating protein (FAP) in major organs and other tissues affected with fibrotic diseases or conditions. This is an observational study in that [F-18]-FAPI-74 PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [F-18]-FAPI-74 PET/CT results, any medical or treatment decisions related to their underlying clinical diagnosis will be made by the treating physicians based upon clinical criteria.
After injection of [F-18]-FAPI-74, patients will undergo a vertex to mid-thigh scan, starting at approximately 15 minutes post injection. PET/CT imaging sessions will include an injection of approximately 8.0 mCi (expected range of doses is expected to be 6.0-8.0 mCi) of [F-18]-FAPI-74 intravenously. Data will be collected to evaluate uptake of [F-18]-FAPI-74 in sites of suspected fibrosis and in major organs.
An optional second PET/CT using [F-18]-FAPI-74 can be considered at the request of the investigators at any clinically relevant time point for the H\&N, Exploratory and Cardiac Sarcoidosis cohorts. This second scan may be used to quantify the changes in fibrosis over time as part of the natural progression of the fibrotic condition, or to observe changes in [F-18]-FAPI-74 uptake in response to therapeutic interventions.
Imaging cohorts include:
Head and neck cancer (up to 15 patients) Post tubercular lung disease (PTLD, up to 10 patients) Cardiac Sarcoidosis (up to 10 patients) Exploratory Cohort (Pilot studies for generating clinical data to support use of the radiotracer for FAP targeted therapies, up to 10 patients)
Uptake of [F-18]-FAPI-74 may be compared to other clinical pathology or lab results related to the presence of fibrosis (e.g. tissue sequencing, genomics, immunohistochemistry, ELISA, and similar assays))
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAPI-74 PET/CT Scan | Experimental | Drug: [F-18]-FAPI-74Head 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
- Participants will be ≥ 21 years of age
Key exclusion criteria (12 listed)
- 1. Patient is not eligible for tissue resection
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F-18]-FAPI-74Also: [18F] aluminium fluorine ((S)-2,2'(7- (2-(4-(3-(4-(2-(2- cyanopyrrolidin-1-yl)-2 oxoethylcarbamoyl)quinolin-6-yloxy) propyl)piperazin-1-yl)-2-oxoethyl)-1,4,7- triazonane-1,4-diyl)diacetic acidA 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). | Drug | FAPI-74 PET/CT Scan |
Primary outcome
Overall FAPI-74 PET/CT Image Analysis
Time frame: 3 years
The overall quality of the generated images will be evaluated. Initial imaging of the vertex to mid-thigh will be used to investigate regional tracer uptake in suspected sites of fibrosis and normal tissues for this novel radiotracer. Uptake and retention of [F-18]-FAPI-74 in known or suspected sites of fibrotic disease will be evaluated visually by trained radiology readers, the principal investigator, or designee. A number of analysis methods may be tested to identify the optimal method for analyses for future studies with this radiotracer. [F-18]-FAPI-74 PET/CT scans will be interpreted both qualitatively and quantitatively.
Head and Neck Cancer FAPI-74 PET/CT Image Analysis
Time frame: 3 years
[18F]-FAPi74 PET/CT data: Areas of uptake in tumors and healthy tissue will be measured by SUVmax and semiquantitative analysis will be conducted. In each case, lesion uptake will be marked as low, medium, and high avidity. Each lesion and lymph node will be separately measured and quantified. Measurements will be made by Dr. Sellmyer and co-Investigators (n=3).
PTLD FAPI-74 PET/CT Image Analysis
Time frame: 3 years
Quantitative interpretation of FAP expression, will be recorded as a Standardized Uptake Value (SUV). Max, mean, and peak SUV values will be recorded for a region-of-interest encompassing a single primary lesion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark A Sellmyer, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [F-18]-FAPI-74 in people with Fibrosis (Morphologic Abnormality), run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Schubert (215-573-6569, erinschu@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall FAPI-74 PET/CT Image Analysis (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.