FAP PET/CT in adults with pulmonary TB

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early-phase, single-arm study evaluating Fibroblast Activating Protein (FAP) PET/CT imaging in adults with microbiologically confirmed pulmonary TB. Participants will have two imaging timepoints: within 6 weeks of TB treatment initiation and within 6 months after TB cure, along with a high-resolution CT. The goal is to see if changes in total lung FAP signal relate to changes in lung damage and to explore potential links to outcomes such as post-treatment complications. The study uses [18F]-FAPI-74 as the imaging agent and is conducted at the University of Pennsylvania and associated clinics.

Why it matters

Who can join: the full rules

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

Where it's running

• Perelman School of Medicine, Nuclear Medicine
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Mark A Sellmyer, MD — UPENN, Gerd Muehllehner Associate Professor of Radiology
• Study coordinator: Mark A Sellmyer, MD
• Email: mark.sellmyer@pennmedicine.upenn.edu
• Phone: (215) 573-3212

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.