Fibroblast Activating Protein (FAP) PET/CT in Adults With Tuberculosis
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.
Studie Overzicht
Gedetailleerde beschrijving
Most participants will be receiving care at the clinical practices of the University of Pennsylvania or through City of Philadelphia TB Control Program (named the Flick clinic). Patients may participate in this study if they are at least 21 years of age and will be approached about study participation regardless of race or ethnic background. The study anticipates enrolling up to 10 participants who meet eligibility requirements for this study. Accrual is estimated to occur over approximately 2 years.
Investigators propose to use Fibroblast Activating Protein (FAP) PET/computed tomography (CT) to define the extent and location of FAP signals in lungs of TB patients at the time of TB treatment initiation 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. This is important, as radiographic findings in TB are associated with mortality.
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.
After injection of [F-18]-FAPI-74, patients will undergo a vertex to mid-thigh scan, starting at approximately 30 minutes (± 5 min) post injection. PET/CT imaging sessions will include an injection of ≤ 8.0 mCi (expected range of doses is expected to be 6.0-8.0 mCi) of [F-18]-FAPI-74 intravenously. Data will be collected to evaluate uptake of [F-18]-FAPI-74 in the lung.
Studietype
Inschrijving (Geschat)
Fase
- Vroege fase 1
Contacten en locaties
Studiecontact
- Naam: Mark A Sellmyer, MD
- Telefoonnummer: (215) 573-3212
- E-mail: mark.sellmyer@pennmedicine.upenn.edu
Studie Contact Back-up
- Naam: Erin Schubert
- Telefoonnummer: (215) 573-6569
- E-mail: erin.schubert@pennmedicine.upenn.edu
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Werving
- Perelman School of Medicine, Nuclear Medicine
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Contact:
- Erin Schubert
- Telefoonnummer: 215-573-6569
- E-mail: erin.schubert@pennmedicine.upenn.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria
- 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.
- Have a Timika CXR score indicating cavitary disease
- Be able and willing to provide written informed consent to participate in the study
Exclusion Criteria
- 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.
- History of major alternative pulmonary disease such as asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as per medical record review or patient self-report. "Major" is defined as potentially resulting in pulmonary radiographic abnormalities that could interfere with interpretation of PET-CT scan data.
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Pulmonary Tuberculosis Cohort
Participants aged 21 years of age or older with a diagnosis of pulmonary Tuberculosis |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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.
Tijdsspanne: 6 months
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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. |
6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Characterize the association between FAP PET signals in lungs early after TB diagnosis and persistent lung structural damage after cure.
Tijdsspanne: 6 months
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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. |
6 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mark A Sellmyer, MD, UPENN, Gerd Muehllehner Associate Professor of Radiology
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB# 25-1425 (859162)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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