Status:

RECRUITING

18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients

Lead Sponsor:

Children's Hospital Medical Center, Cincinnati

Collaborating Sponsors:

National Institutes of Health (NIH)

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Tuberculosis, Pulmonary

Eligibility:

All Genders

18+ years

Brief 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 pos...

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.

Key Trial Info

Start Date :

March 12 2026

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT07077213

Start Date

March 12 2026

End Date

December 1 2027

Last Update

March 31 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients | DecenTrialz