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

NCT07830771 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB# 25-1425 (859162)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

pTB; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  6 months

Study Arms (1)

Pulmonary Tuberculosis Cohort

EXPERIMENTAL

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

Drug: [18F]-FAPI-74

Interventions

[18F]-FAPI-74 DRUG

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.

Pulmonary Tuberculosis Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Perelman School of Medicine, Nuclear Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mark A Sellmyer, MD

  UPENN, Gerd Muehllehner Associate Professor of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark A Sellmyer, MD

CONTACT

(215) 573-3212; mark.sellmyer@pennmedicine.upenn.edu

Erin Schubert

CONTACT

(215) 573-6569; erin.schubert@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 21, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2030
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

US (1)