18F-FAPI-74 in Tuberculosis Patients

Launched by JOHNS HOPKINS UNIVERSITY · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to look at lung damage caused by tuberculosis (TB) using a special type of scan called a PET scan with a tracer named 18F-FAPI-74. The researchers want to see if this scan can safely and easily detect scarring (fibrosis) in the lungs after TB infection, which could help doctors better understand and monitor lung health in TB patients without needing invasive tests.

Adults who have been diagnosed with active TB through lab tests and have signs of TB in their lungs on imaging like X-rays or CT scans may be eligible to join. Participants will receive an injection of the tracer and then have a whole-body PET scan to look for lung damage. This scan may be done either soon after starting TB treatment or after completing about six months of treatment, and some patients might be scanned at both times. To join, participants must be able to give informed consent, have normal lab test results, and not have conditions that would make the scan unsafe. Women who could become pregnant will need a negative pregnancy test before the scan. This study is not yet recruiting but aims to provide a new, less invasive way to assess lung damage from TB in the future.

Gender

ALL

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-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.