Actively Recruiting
Biodistribution and Pathophysiology Study of 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-31
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) positron emission tomography (PET) as a noninvasive biomarker to assess lung disease and fibrosis in patients with active tuberculosis (TB). The study focuses on microbiologically confirmed TB patients to determine if 18F-FAPI-74 PET can detect fibrosis in TB lesions with high sensitivity. Participants will receive a single intravenous dose of 18F-FAPI-74 followed by a PET/CT scan performed either during the first six weeks of TB treatment or within six weeks after completing six months of TB treatment. Some patients may have a second PET/CT scan after treatment completion to compare findings. This process allows assessment of fibrosis at different stages of TB treatment. During the study, participants will undergo whole-body PET scans after injection of 18F-FAPI-74, with imaging correlated to sites of TB lesions identified on computed tomography (CT). Researchers will measure the uptake of 18F-FAPI-74 using standardized uptake values within one hour. Participants will provide informed consent and comply with scheduled visits and procedures. Safety and laboratory tests will be monitored throughout the study.
CONDITIONS
Brief Title
18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Microbiological confirmation of Mycobacterium tuberculosis by culture or molecular test (GeneXpert)
- Imaging evidence of suspected tuberculosis involving lungs or other sites using modalities like chest x-ray, CT, ultrasound, MRI, PET/CT, or bone scan
- TB treatment started within 6 weeks before the study PET/CT scan or within 6 weeks after completing 6 months of treatment
- Willing to provide written informed consent
- Able to comply with study procedures and scheduled visits
- Screening lab tests within normal limits or not clinically significant
- Women of child-bearing potential must have a negative pregnancy test within 24 hours before radiotracer injection
- Ability to read, understand, and provide informed consent for study procedures
You will not qualify if you...
- Inadequate venous access sites for injection and blood sampling
- Currently breastfeeding
- Received a radioisotope within 5 physical half-lives before enrollment
- Prior radiation exposure from research exceeding 5 rems annually
- Any medical condition judged by investigators to make participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive an intravenous dose of 18F-FAPI-74 followed by a PET/CT scan during the first 6 weeks of tuberculosis treatment.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive a second intravenous dose of 18F-FAPI-74 followed by a PET/CT scan within 6 weeks after completing tuberculosis treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
S
Sanjay K Jain, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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