NCT07077213 · Children's Hospital Medical Center, Cincinnati
18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients
What this study 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.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
18F-FAPI-74
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.
Primary outcome measures
Uptake of 18F-FAPI-74 derived by the standardized uptake value ratio (SUVr)
Time frame: Up to 1 hour
Characterization of lesional fibrosis using 18F-FAPI-74 PET/CT in tuberculosis patients. Whole-body PET/CT scans will be obtained after intravenous injection of 18F-FAPI-74. Uptake will be measured at sites of TB lesions and unaffected areas.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Cincinnati, Ohio
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), SOFIE
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations