Recruiting
Early Phase 1

FAP Activation

Sponsor:

University of Pennsylvania

Code:

NCT07830771

Conditions

Tuberculosis, Pulmonary

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

[18F]-FAPI-74

Study Details

Brief 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. 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.

Conditions

Tuberculosis, Pulmonary

Study ID

NCT07830771

Start date

Sep 30, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Pulmonary Tuberculosis Cohort

Participants aged 21 years of age or older with a diagnosis of pulmonary Tuberculosis

Interventions

[18F]-FAPI-74

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.

Primary outcome measure

  • 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. [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Perelman School of Medicine, Nuclear Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • pTB
  • Tuberculosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.