NCT07077213 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients
| NCT ID | NCT07077213 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Tuberculosis, Pulmonary |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-12 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-03-12 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Sanjay Jain, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT07077213 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tuberculosis, Pulmonary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07077213 currently recruiting?
Yes, NCT07077213 is actively recruiting participants. Contact the research team at sanjay.jain@cchmc.org for enrollment information.
Where is the NCT07077213 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT07077213 clinical trial?
NCT07077213 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Sanjay Jain, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 30 participants.