RecruitingEarly phase 1interventionalRules rewrite

Early phase 1: testing [18F]-FAPI-74 for Tuberculosis, Pulmonary

This is an early phase study in patients with Tuberculosis (TB) to evaluate Fibroblast Activating Protein (FAP) activation as a marker of fibrosis. The Investigators propose to use FAP PET/CT to define the extent and location of FAP signals in lungs of TB patients early in TB treatment and after TB cure.

Official registry: https://clinicaltrials.gov/study/NCT07830771 · University of Pennsylvania · enrollment listed as 10

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are [18F]-FAPI-74. The registry lists allocation as na. This is an early phase study in patients with Tuberculosis (TB) to evaluate Fibroblast Activating Protein (FAP) activation as a marker of fibrosis.

They plan to enroll about 10 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Fibroblast Activating Protein (FAP) PET/CT in Adults With Tuberculosis

Interventions: [18F]-FAPI-74

Primary outcome (registry wording): Determine the relationship between change in FAP PET signals in lungs during TB treatment and change in lung structural damage in adult patients treated for pulmonary TB.

Who it is for (from inclusion criteria)

Ages 21 Years to any
you would be ≥ 21 years of age
Diagnosed with microbiologically confirmed (culture or Xpert MTB/RIF PCR positive on at least one respiratory sample) pTB
Be currently on or able to initiate standard drug-sensitive pTB treatment according to IDSA guidelines
Have initiated or planning to initiate TB treatment prior to screening and enrollment
Have a Timika CXR score indicating cavitary disease

Who the registry excludes

Diagnosed with TB that is resistant to rifampin per medical record review or have only extrapulmonary TB
Women of childbearing potential may not be pregnant or breast-feeding. A negative pregnancy test will be required before \[F-18\]-FAPI-74 injection
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
Have been administered at least 7 days of corticosteroids or any duration of another systemic investigational agent within 3 months of enrollment per medical record review or patient self-report
Have symptoms or signs that, in the opinion of the investigative team, are suggestive of active TB at the time of pre-screening per patient self-report

Public study contact (from the registry)

Mark A Sellmyer, MD

(215) 573-3212

mark.sellmyer@pennmedicine.upenn.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Perelman School of Medicine, Nuclear Medicine — Philadelphia, Pennsylvania (recruiting)

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FAQ about this NCT record

Is NCT07830771 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07830771?

Early phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07830771?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary