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

Conditions

• Tuberculosis, Pulmonary

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 18F-FAPI-74 — COMBINATION_PRODUCT
  7 millicurie (mCi) of 18F-FAPI-74 in adult tuberculosis patient followed by a PET/CT scan, performed during the first 6 weeks of treatment and/or a second dose of 7 millicurie (mCi) of 18F-FAPI-74 in adult tuberculosis patient followed by a PET/CT scan within 6 weeks after tuberculosis treatment completion.

Study Details

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.

Key Dates

Start date

Mar 12, 2026

Status verified

Mar 2026

Primary completion

Jul 1, 2027

Completion

Dec 1, 2027

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: 18F-FAPI-74 PET/CT
  A single intravenous dose of 18F-FAPI-74 followed by PET/CT scan pre- and post-TB treatment.

Primary Outcome Measure

Uptake of 18F-FAPI-74 derived by the standardized uptake value ratio (SUVr) [ Time Frame: Up to 1 hour ]

Central Contacts

• Sanjay K Jain, MD
  513-636-7056
  [email protected]

Locations (1)

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