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Biodistribution and Pathophysiology Study of 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Observational
SUMMARY

The investigators will assess the hypothesis is that 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) Positron emission tomography (PET) could be used as a noninvasive biomarker to assess post-tuberculosis (post-TB) lung disease and fibrosis in TB patients. Microbiologically confirmed patients with active tuberculosis will be invited to participate in the study. A whole-body PET scan will be performed after 18F-FAPI-74 intravenous injection and correlation will be made with sites of TB lesions noted on CT. It is anticipated that 18F-FAPI-74 PET will be able to detect fibrosis (with high sensitivity) in the TB lesions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Greater than or equal to 18 years of age

• Culture confirmation of M. tuberculosis, or sputum positive by molecular testing (GeneXpert).

• Imaging evidence of suspected M. tuberculosis disease involving lung, and possible additional other sites of involvement. Modalities can include any imaging modality such as chest x-ray, CT, ultrasound, MRI, 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (\[18F\]FDG) PET/CT, bone scan.

• TB treatment initiation within 6-weeks by the time of the study PET/CT scan OR within 6-weeks after receiving 6-months of TB treatments. Using this approach, we will be able to assess fibrosis in TB patients at treatment initiation as well as having received TB treatments. The same patient may be re-consented for a scan at the later time-point.

• Subject is willing to give written informed consent.

• Subject is willing and able to comply with the protocol for the duration of the study including undergoing scheduled visits and study procedures.

• Screening clinical laboratory values must be within normal limits or judged not clinically significant by the investigator.

• Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the radiotracer administration.

• Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Sanjay K Jain, MD
sanjay.jain@cchmc.org
513-636-7056
Time Frame
Start Date: 2026-03-12
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 30
Treatments
18F-FAPI-74 PET/CT
A single intravenous dose of 18F-FAPI-74 followed by PET/CT scan pre- and post-TB treatment.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), SOFIE, National Institutes of Health (NIH)
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov