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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: sanjay.jain@cchmc.org
• Phone: 513-636-7056

Similar studies

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

• FAP PET/CT in adults with pulmonary TB

  This early-phase study tests whether a FAP PET/CT scan can map lung fibrosis in adults with pulmonary TB before starting treatment and after cure.

  Recruiting Early Phase 1 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07830771

• Sorfequiline-based regimens for adults with newly diagnosed drug-sensitive pulmonary TB

  This study tests two sorfequiline-containing regimens, each with pretomanid and linezolid, to see if they are safe and effective in adults with newly diagnosed drug-sensitive pulmonary TB.

  Recruiting at 6 sites Phase 2 Global Alliance for TB Drug Development · Wentworth, Durban and 11 other locations · NCT07672405

• Digital health tool to help more people start TB preventive therapy

  A digital health approach is being tested to see if it helps household and close contacts of people with drug-sensitive pulmonary TB start TB preventive therapy better.

  Recruiting at 8 sites Arba Minch University · Arba Minch, South Ethiopia and 13 other locations · NCT07313995

• Ear acupuncture to reduce nausea and vomiting from tuberculosis medicines

  This trial will test whether press-needle ear acupuncture can reduce nausea and vomiting in people taking medicines for pulmonary tuberculosis.

  Recruiting Universitas Indonesia · Jakarta, Jakarta Timur · NCT07271225

• Blood TB DNA test to track treatment progress

  This project will test whether levels of TB-derived cell-free DNA in the blood can track treatment response in adults newly diagnosed with tuberculosis.

  Recruiting University of Oxford · Tak · NCT06845618

• ID93+GLA‑SE vaccine for tuberculosis prevention in adults 55–74

  This study will try three doses of the ID93+GLA‑SE vaccine to see if they are safe and boost immune responses in BCG‑vaccinated adults aged 55–74 compared with a saline placebo.

  Recruiting at 4 sites Phase 1 Quratis Inc. · Gwangmyeong, Gyeonggi-do and 3 other locations · NCT06714513

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.