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18F-FAPI-74 in Tuberculosis Patients

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

NCT07077213•Johns Hopkins University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Key Dates

Start Date

February 1, 2026

Primary Completion Date

July 1, 2027

Completion Date

December 1, 2027

Last Updated

December 11, 2025

Enrollment

ESTIMATED participants

Conditions

Tuberculosis, Pulmonary

Interventions

18F-FAPI-74

COMBINATION_PRODUCT

Contacts

Sanjay K Jain, MD

CONTACT

4105028241 sjain5@jhmi.edu

Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students

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TuberculosisTuberculosis, Pulmonary+3 more

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RECRUITING

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Tuberculosis, Pulmonary

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COMPLETEDPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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18F-FAPI-74 in Tuberculosis Patients

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