Actively Recruiting
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
89 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
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.
CONDITIONS
Official 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
- Confirmed tuberculosis by culture or molecular test (GeneXpert)
- Imaging evidence of suspected tuberculosis involving the lungs or other sites by chest x-ray, CT, ultrasound, MRI, PET/CT, or bone scan
- TB treatment started within 6 weeks before the PET/CT scan or within 6 weeks after completing 6 months of treatment
- Willing to provide written informed consent
- Able to follow the study protocol and attend scheduled visits and procedures
- Screening lab results within normal limits or not clinically significant
- Women of child-bearing potential must have a negative pregnancy test within 24 hours before radiotracer administration
- Ability to read, understand, and provide written informed consent for study procedures
You will not qualify if you...
- Inadequate venous access (need two access sites for drug injection and blood sampling)
- Currently lactating
- Received a radioisotope within 5 physical half-lives before enrollment as part of research
- Prior external radiation exposure from research exceeding 5 rems annual limit
- Any medical condition that makes the patient unsuitable for the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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