ClinicalTrials.gg
RecruitingNCT07077213Updated Mar 31, 2026

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

An observational study in Tuberculosis, Pulmonary, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Children's Hospital Medical Center, Cincinnati · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tuberculosis, Pulmonary
03

In context

Tuberculosis, Pulmonary

319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.

This study's planned enrollment of 30 is below the median of 300 across 83 observational studies indexed under Tuberculosis, Pulmonary.

Browse Tuberculosis, Pulmonary studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate.

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 .
  • 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 by the investigator.
  • Women of (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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 18F-FAPI-74 PET/CT

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

    Combination Product: 18F-FAPI-74

Interventions

  • Combination product18F-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.

06

What researchers measure

Primary outcomes

  1. Uptake of 18F-FAPI-74 derived by the standardized uptake value ratio (SUVr)

    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.

    Time frame: Up to 1 hour

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07077213
Responsible party
Sponsor
First posted
Jul 22, 2025
Start date
Mar 12, 2026
Primary completion
Jul 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Mar 31, 2026

Study contacts

Sanjay K Jain, MD
Contact
sanjay.jain@cchmc.org
513-636-7056
Sanjay Jain, MD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion