Fibroblast Activating Protein (FAP) PET/CT in Adults With Tuberculosis

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Early Phase 1

Age range

21 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

10 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria

1. Participants will be ≥ 21 years of age
2. Diagnosed with microbiologically confirmed (culture or Xpert MTB/RIF PCR positive on at least one respiratory sample) pTB
3. Be currently on or able to initiate standard drug-sensitive pTB treatment according to IDSA guidelines.
4. Have initiated or planning to initiate TB treatment prior to screening and enrollment.
5. Have a Timika CXR score indicating cavitary disease
6. Be able and willing to provide written informed consent to participate in the study

Exclusion Criteria

1. Diagnosed with TB that is resistant to rifampin per medical record review or have only extrapulmonary TB.
2. Women of childbearing potential may not be pregnant or breast-feeding. A negative pregnancy test will be required before \[F-18\]-FAPI-74 injection.
3. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
4. 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.
5. 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.
6. 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
7. 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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University of Pennsylvania

Study start

Sep 22, 2026 Actual

Primary completion

Sep 30, 2028 Estimated

Study completion

Sep 30, 2030 Estimated

First posted

Sep 21, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts