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

ConditionTuberculosis, Pulmonary

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age21+

SponsorUniversity of Pennsylvania

About this trial

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. These timepoints are chosen as they could be utilized to deliver treatments designed to prevent, predict, or treat Post-transplant Lymphoproliferative Disorder (PTLD). The overarching hypothesis is that greater FAP signals in lungs of adult TB patients are associated with greater imaging manifestations of PTLD after cure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants will 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.

Disqualifiers

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

Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study, including completion of the study follow-up or TB treatment.

Trial design

Design model

Single group

Treatments tested in this trial

[18F]-FAPI-74
Drug
Each patient will receive approximately 8 mCi of \[18F\]-FAPI-74 intravenously (approximate range for most studies is anticipated to be 6-8 mCi). This will be followed by a vertex to thigh static scan at 30 minutes ( ±5 min) post injection and a low dose CT for attenuation correction. Participants will also undergo high-resolution CT (HRCT) of the chest at baseline and follow-up timepoints, these scans may be done the same day or on different days.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Pulmonary Tuberculosis CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Greater radiographic lung structural damage in TB, a hallmark of PTLD, is inversely associated with lung function and has repeatedly been associated with reduced survival in TB5, 21-23. This longitudinal study will perform FAP PET/CT and high-resolution CT (HRCT) within 6 weeks of TB treatment initiation and again within 6 months after TB cure to evaluate the hypothesis that change in total pulmonary FAP signal during treatment is associated with change in a measure of total lung structural damage previously validated in TB. It is expected that patients with less decrease in FAP lung signals will have less improvement in lung structural damage despite curative TB treatment.

Time frame

6 months

Secondary outcomes

Characterize the association between FAP PET signals in lungs early after TB diagnosis and persistent lung structural damage after cure.

Investigators will use the longitudinal data from Aim 1 to evaluate the hypothesis that higher levels of total FAP signal in the lungs early will be associated with higher overall levels of residual structural lung damage on HRCT after TB cure. It is expected that higher baseline FAP signal will be associated with worse residual structural lung damage.

Time frame

6 months

Sponsors and contacts

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University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov

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