Tuberculosis, PulmonaryEarly Phase 1NCT07830771
Fibroblast Activating Protein (FAP) PET/CT in Adults With Tuberculosis
A Early Phase 1 study testing [18F]-FAPI-74 in people with Tuberculosis, Pulmonary, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is an early phase study in patients with Tuberculosis (TB) to evaluate Fibroblast Activating Protein (FAP) activation as a marker of fibrosis. The Investigators propose to use FAP PET/CT to define the extent and location of FAP signals in lungs of TB patients early in TB treatment and after TB cure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- [18F]-FAPI-74
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 30 Sep 2030
- Phase
- Early Phase 1
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
- Participants will be ≥ 21 years of age
- Diagnosed with microbiologically confirmed (culture or Xpert MTB/RIF PCR positive on at least one respiratory sample) pTB
- Be currently on or able to initiate standard drug-sensitive pTB treatment according to IDSA guidelines.
- Have initiated or planning to initiate TB treatment prior to screening and enrollment.
- Have a Timika CXR score indicating cavitary disease
- Be able and willing to provide written informed consent to participate in the study
Who cannot join
- Diagnosed with TB that is resistant to rifampin per medical record review or have only extrapulmonary TB.
- Women of childbearing potential may not be pregnant or breast-feeding. A negative pregnancy test will be required before [F-18]-FAPI-74 injection.
- 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, including completion of the study follow-up or TB treatment.
- History of major alternative pulmonary disease such as asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as per medical record review or patient self-report. "Major" is defined as potentially resulting in pulmonary radiographic abnormalities that could interfere with interpretation of PET-CT scan data.
- Have been administered at least 7 days of corticosteroids or any duration of another systemic investigational agent within 3 months of enrollment per medical record review or patient self-report
- Have symptoms or signs that, in the opinion of the investigative team, are suggestive of active TB at the time of pre-screening per patient self-report
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
Perelman School of Medicine, Nuclear Medicine
Philadelphia, Pennsylvania, 19104
Erin Schubert, 215-573-6569, erin.schubert@pennmedicine.upenn.edu
About this study
This is an early phase study in patients with Tuberculosis (TB) to evaluate Fibroblast Activating Protein (FAP) activation as a marker of fibrosis. The Investigators propose to use FAP PET/CT to define the extent and location of FAP signals in lungs of TB patients early in TB treatment and after TB cure. These timepoints are chosen as they could be utilized to deliver treatments designed to prevent, predict, or treat Post-transplant Lymphoproliferative Disorder (PTLD). The overarching hypothesis is that greater FAP signals in lungs of adult TB patients are associated with greater imaging manifestations of PTLD after cure.
Read the detailed description
Most participants will be receiving care at the clinical practices of the University of Pennsylvania or through City of Philadelphia TB Control Program (named the Flick clinic). Patients may participate in this study if they are at least 21 years of age and will be approached about study participation regardless of race or ethnic background. The study anticipates enrolling up to 10 participants who meet eligibility requirements for this study. Accrual is estimated to occur over approximately 2 years.
Investigators propose to use Fibroblast Activating Protein (FAP) PET/computed tomography (CT) to define the extent and location of FAP signals in lungs of TB patients at the time of TB treatment initiation and after TB cure. These timepoints are chosen as they could be utilized to deliver treatments designed to prevent, predict, or treat Post-transplant Lymphoproliferative Disorder (PTLD). The overarching hypothesis is that greater FAP signals in lungs of adult TB patients are associated with greater imaging manifestations of PTLD after cure. This is important, as radiographic findings in TB are associated with mortality.
This longitudinal study will perform FAP PET/CT and high-resolution CT (HRCT) within 6 weeks of TB treatment initiation and again within 6 months after TB cure to evaluate the hypothesis that change in total pulmonary FAP signal during treatment is associated with change in a measure of total lung structural damage previously validated in TB. It is expected that patients with less decrease in FAP lung signals will have less improvement in lung structural damage despite curative TB treatment.
After injection of [F-18]-FAPI-74, patients will undergo a vertex to mid-thigh scan, starting at approximately 30 minutes (± 5 min) post injection. PET/CT imaging sessions will include an injection of ≤ 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 the lung.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- [18F]-FAPI-74
- Keywords
- pTB, Tuberculosis
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-FAPI-74Drug
Each patient will receive approximately 8 mCi of [18F]-FAPI-74 intravenously (approximate range for most studies is anticipated to be 6-8 mCi). This will be followed by a vertex to thigh static scan at 30 minutes ( ±5 min) post injection and a low dose CT for attenuation correction. Participants will also undergo high-resolution CT (HRCT) of the chest at baseline and follow-up timepoints, these scans may be done the same day or on different days.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Tuberculosis Cohort | Experimental | Participants aged 21 years of age or older with a diagnosis of pulmonary Tuberculosis Receives: Drug: [18F]-FAPI-74 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the relationship between change in FAP PET signals in lungs during TB treatment and change in lung structural damage in adult patients treated for pulmonary TB.
Greater radiographic lung structural damage in TB, a hallmark of PTLD, is inversely associated with lung function and has repeatedly been associated with reduced survival in TB5, 21-23. This longitudinal study will perform FAP PET/CT and high-resolution CT (HRCT) within 6 weeks of TB treatment initiation and again within 6 months after TB cure to evaluate the hypothesis that change in total pulmonary FAP signal during treatment is associated with change in a measure of total lung structural damage previously validated in TB. It is expected that patients with less decrease in FAP lung signals will have less improvement in lung structural damage despite curative TB treatment.
Measured: 6 months
Secondary outcomes (1)
Characterize the association between FAP PET signals in lungs early after TB diagnosis and persistent lung structural damage after cure.
Investigators will use the longitudinal data from Aim 1 to evaluate the hypothesis that higher levels of total FAP signal in the lungs early will be associated with higher overall levels of residual structural lung damage on HRCT after TB cure. It is expected that higher baseline FAP signal will be associated with worse residual structural lung damage.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study will use a longitudinal mixed effects model including the baseline Lung-FAV as the independent variable and the hard volume at follow-up as the dependent variable. Given baseline lung structural damage is a predictor of follow-up lung structural damage, the study will include baseline hard volume scores in the multivariable model. This model will therefore express the association between baseline FAP signals in the lung and structural damage at follow-up taking into account the radiographic severity of TB at presentation.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Sellmyer, MD, Principal investigator, UPENN, Gerd Muehllehner Associate Professor of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830771
- Sponsor's protocol ID
- IRB# 25-1425 (859162)
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No