18F-FAPI-74 PET imaging for lung fibrosis in tuberculosis

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

This project tries to see if 18F-FAPI-74 PET scans can detect lung fibrosis in adults with active or recently treated tuberculosis.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT07077213 on ClinicalTrials.gov

What this trial studies

This observational imaging protocol uses the fibroblast-activation–targeted tracer 18F-FAPI-74 with whole-body PET to look for fibrosis in patients with microbiologically confirmed tuberculosis. Participants receive an IV injection of 18F-FAPI-74 followed by PET imaging, and uptake patterns will be compared with sites of disease seen on CT and other clinical imaging. Scans may be performed near treatment initiation (within six weeks) or after completion of six months of therapy, and individual patients may be rescanned at the later time point. The goal is to determine whether 18F-FAPI-74 PET can noninvasively identify fibrotic changes in post-TB lung lesions with high sensitivity.

Who should consider this trial

Good fit: Adults (age ≥18) with microbiologically confirmed pulmonary tuberculosis and imaging evidence of lung involvement who are willing to consent and can be scanned within six weeks of treatment start or after completing six months of therapy.

Not a fit: People without pulmonary involvement, children under 18, those unable to undergo PET imaging, or patients with exclusively extrapulmonary TB are unlikely to benefit from this imaging approach.

Why it matters

Potential benefit: If successful, this approach could provide a noninvasive way to detect and map lung fibrosis after TB, which may help guide follow-up and management.

How similar studies have performed: FAPI PET tracers have shown promise imaging fibroblast activity and fibrosis in cancer and some fibrotic diseases, but their application specifically to tuberculosis-related lung fibrosis is novel with limited prior TB-specific data.

Eligibility criteria

Inclusion criteria: Patients may be enrolled into this protocol only if all the following inclusion criteria are met:

* 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.

Exclusion criteria: Patients will be excluded from enrollment if any of the following apply:

* Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and pharmacokinetics (PK) blood sampling, respectively)
* Lactating females
* Administered a radioisotope within 5 physical half-lives as part of a research study prior to study enrollment.
* Determined to have prior (external) radiation exposure from research studies which will exceed Radioactive Drug Research Committee (RDRC) annual radiation exposure limit of 5 rems.
* Any medical condition that in the judgment of the investigator would make the patient inappropriate for entry into this study.

Where this trial is running

Cincinnati, Ohio

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Sanjay Jain, MD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Sanjay K Jain, MD

Conditions Tuberculosis, Pulmonary