Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
Evaluation of Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74 PET/CT Imaging)
Background:
Injury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.
Objective:
To test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.
Eligibility:
People aged 18 years and older with lung or heart disease that may cause scarring in those organs.
Design:
Participants will have 6 clinic visits over 2 years.
Participants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart.
The study tracer will be used with positron emission tomography (PET)/computed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine.
Participants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits.
Participants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Study Description:
Fibroblast activation protein-targeted PET detects activated fibroblasts in a range of inflammatory and fibrosing cardiovascular and pulmonary disorders. It is a sensitive and quantifiable intervention to diagnose and monitor the natural history of cardiopulmonary disorders and/or the effects of antifibrotic interventions.
Objectives:
Primary objective:
To compare 18F-FAPI-74 PET/CT to standard of care (SOC) imaging (18F-FDG-PET/CT, non-contrast chest CT, and cardiac MRI for heart cohort) to detect fibrosis.
Secondary objective:
To compare the ability of 18F-FAPI-74 PET/CT imaging to assess the natural history or treatment responses with standard of care imaging in cardiopulmonary diseases associated with fibrosis.
Exploratory objectives:
To use high density proteomic, transcriptomic, and metagenomic analysis of specimens from lung and/or blood to define associated mechanisms and biomarkers of active fibrosis with the visualization and quantification of FAP expression. To assess the usefulness of cardiopulmonary imaging with low-field heart lung MRI for characterization of the lung microarchitecture, microvascular perfusion, regional ventilation, and late gadolinium enhancement.
Endpoints:
Primary:
Compare 18F-FAPI-74 PET/CT to standard of care (SOC) imaging with 18F-FDG-PET/CT (with the rate of concordance defined as a quantitative measure of the abnormal lung parenchyma detected in both the FAPI and FDG PET scans ranging from 0 to 100%) and cardiac MRI for heart cohort for the development of pulmonary or cardiovascular fibrosis at baseline These findings will be evaluated separately in six different at-risk cohorts (allogeneic stem cell transplant, lung allograft transplant, interstitial lung disease, acute lung injury, pulmonary arterial hypertension, and cardiovascular disease).
Secondary:
Compare the ability of 18F-FAPI-74 PET/CT imaging to assess the progression of fibrosis or treatment response compared to SOC imaging. The magnitude of change in 18F-FAPI-74 PET/CT uptake (SUVmax and mean/median) between scans one and two will be compared. Comparisons of the quantitative chest CT abnormalities will be compared to both 18F-FAPI-74 PET/CT and 18F-FDGPET/CT scans. These findings will be evaluated separately in six different at-risk cohorts (allogeneic stem cell transplant, lung allograft transplant, interstitial lung disease, acute lung injury, pulmonary arterial hypertension, and cardiovascular disease). Comparison of 18F-FAPI-74 PET/CT to standard of care (SOC) imaging at up to 12 months after the initial scan at baseline and change from the baseline.
Exploratory:
To use high density proteomic, transcriptomic, and metagenomic analysis of specimens from lung and/or blood to define associated biomarkers and mechanisms of active fibrosis with the visualization and quantitation of FAP expression. To assess the usefulness of
cardiopulmonary imaging with low-field heart lung MRI for characterization of the lung microarchitecture, microvascular perfusion, regional ventilation, and late gadolinium enhancement.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Anthony F Suffredini, M.D.
- Telefonnummer: (301) 496-9320
- E-post: asuffredini@mail.nih.gov
Studera Kontakt Backup
- Namn: Rosemary McConnell, R.N.
- Telefonnummer: (301) 827-9716
- E-post: rosemary.mcconnell@nih.gov
Studieorter
-
-
Maryland
-
Bethesda, Maryland, Förenta staterna, 20892
- Rekrytering
- National Institutes of Health Clinical Center
-
Kontakt:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Telefonnummer: TTY dial 711 800-411-1222
- E-post: ccopr@nih.gov
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
- INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Participant >=18 years old
- Has a specific diagnosis of a cardiopulmonary and/or vascular disease that puts them at risk of developing or having developed tissue fibrosis.
- Has undergone prior imaging of lungs, heart, and/or vasculature with chest CT
- Able to lie on the PET/CT scanner for imaging up to 45 minutes.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of FAPI-PET/CT or the FDG PET/CT scan.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of FAPI-PET/CT or the FDG PET/CT scan.
- Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study.
- Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements
- Pregnancy or lactation
- Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study and 4 weeks after the last 18F-FAPI-74 PET/CT scan or the FDG PET/CT scan.
- Subjects with severe claustrophobia unresponsive to oral anxiolytics.
- Subjects weighing > 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Acute lung injury
Acute lung injury undergoing FAPI/PET/CT
|
Fibroblast activation protein-targeted PET detects activated fibroblasts in a range of inflammatory and fibrosing cardiovascular and pulmonary disorders.
It is a sensitive and quantifiable intervention to diagnose and monitor the natural history of cardiopulmonary disorders and/or the effects of antifibrotic interventions.
Participants will undergo baseline diagnostic 18F-FAPI-74 PET/CT in addition to standard of care imaging (non-contrast chest CT and 18FFDG- PET/CT, cardiac MRI for heart cohort).
A follow-up 18F-FAPI- 74 PET/CT with SOC imaging will be performed at 8 to 12 months after the initial scan to assess progression and or the effects of therapies.
|
|
Övrig: Allogeneic stem cell transplantation
Allogeneic stem cell transplantation undergoing FAPI/PET/CT
|
Fibroblast activation protein-targeted PET detects activated fibroblasts in a range of inflammatory and fibrosing cardiovascular and pulmonary disorders.
It is a sensitive and quantifiable intervention to diagnose and monitor the natural history of cardiopulmonary disorders and/or the effects of antifibrotic interventions.
Participants will undergo baseline diagnostic 18F-FAPI-74 PET/CT in addition to standard of care imaging (non-contrast chest CT and 18FFDG- PET/CT, cardiac MRI for heart cohort).
A follow-up 18F-FAPI- 74 PET/CT with SOC imaging will be performed at 8 to 12 months after the initial scan to assess progression and or the effects of therapies.
|
|
Övrig: Cardiovascular diseases
Cardiovascular diseases undergoing FAPI/PET/CT
|
Fibroblast activation protein-targeted PET detects activated fibroblasts in a range of inflammatory and fibrosing cardiovascular and pulmonary disorders.
It is a sensitive and quantifiable intervention to diagnose and monitor the natural history of cardiopulmonary disorders and/or the effects of antifibrotic interventions.
Participants will undergo baseline diagnostic 18F-FAPI-74 PET/CT in addition to standard of care imaging (non-contrast chest CT and 18FFDG- PET/CT, cardiac MRI for heart cohort).
A follow-up 18F-FAPI- 74 PET/CT with SOC imaging will be performed at 8 to 12 months after the initial scan to assess progression and or the effects of therapies.
|
|
Övrig: Interstitial lung disease
Interstitial lung disease undergoing FAPI/PET/CT
|
Fibroblast activation protein-targeted PET detects activated fibroblasts in a range of inflammatory and fibrosing cardiovascular and pulmonary disorders.
It is a sensitive and quantifiable intervention to diagnose and monitor the natural history of cardiopulmonary disorders and/or the effects of antifibrotic interventions.
Participants will undergo baseline diagnostic 18F-FAPI-74 PET/CT in addition to standard of care imaging (non-contrast chest CT and 18FFDG- PET/CT, cardiac MRI for heart cohort).
A follow-up 18F-FAPI- 74 PET/CT with SOC imaging will be performed at 8 to 12 months after the initial scan to assess progression and or the effects of therapies.
|
|
Övrig: Lung allograft transplantation
Lung allograft transplantation undergoing FAPI/PET/CT
|
Fibroblast activation protein-targeted PET detects activated fibroblasts in a range of inflammatory and fibrosing cardiovascular and pulmonary disorders.
It is a sensitive and quantifiable intervention to diagnose and monitor the natural history of cardiopulmonary disorders and/or the effects of antifibrotic interventions.
Participants will undergo baseline diagnostic 18F-FAPI-74 PET/CT in addition to standard of care imaging (non-contrast chest CT and 18FFDG- PET/CT, cardiac MRI for heart cohort).
A follow-up 18F-FAPI- 74 PET/CT with SOC imaging will be performed at 8 to 12 months after the initial scan to assess progression and or the effects of therapies.
|
|
Övrig: Pulmonary arterial hypertension
Pulmonary arterial hypertension undergoing FAPI/PET/CT
|
Fibroblast activation protein-targeted PET detects activated fibroblasts in a range of inflammatory and fibrosing cardiovascular and pulmonary disorders.
It is a sensitive and quantifiable intervention to diagnose and monitor the natural history of cardiopulmonary disorders and/or the effects of antifibrotic interventions.
Participants will undergo baseline diagnostic 18F-FAPI-74 PET/CT in addition to standard of care imaging (non-contrast chest CT and 18FFDG- PET/CT, cardiac MRI for heart cohort).
A follow-up 18F-FAPI- 74 PET/CT with SOC imaging will be performed at 8 to 12 months after the initial scan to assess progression and or the effects of therapies.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To compare 18F-FAPI-74 PET/CT to standard of care imaging (non-contrast chest CT and 18F-FDG-PET/CT, cardiac MRI for heart cohort) to detect fibrosis.
Tidsram: Initial scan, Baseline, 8-12 months
|
Compare 18F-FAPI-74 PET/CT to standard of care (SOC) imaging with 18F-FDG-PET/CT with the rate of concordance defined as a quantitative measure of the abnormal lung parenchyma detected in both the FAPI and FDG PET scans ranging from 0 to 100% and cardiac MRI for heart cohort for the development of pulmonary or cardiovascular fibrosis at baseline.
|
Initial scan, Baseline, 8-12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To compare the ability of 18F-FAPI-74 PET/CT imaging to assess the natural history or treatment responses with standard of care imaging in cardiopulmonary diseases associated with fibrosis
Tidsram: Baseline, 8-12 months
|
Compare the ability of 18F-FAPI-74 PET/CT imaging to assess the progression of fibrosis or treatment response compared to SOC imaging.
The magnitude of change in 18F-FAPI-74 PET/CT uptake (SUVmax and mean/median) between scans one and two will be compared.
Comparisons of the quantitative chest CT abnormalities will be compared to both 18F-FAPI-74 PET/CT and 18F-FDG-PET/CT scans.
These findings will be evaluated separately in six different at-risk cohorts (allogeneic stem cell transplant, lung allograft transplant, interstitial lung disease, acute lung injury, pulmonary arterial hypertension, and cardiovascular disease).
|
Baseline, 8-12 months
|
|
To compare the ability of 18F-FAPI-74 PET/CT imaging to assess the natural history or treatment responses with standard of care imaging in cardiopulmonary diseases associated with fibrosis
Tidsram: Baseline, 8-12 months
|
Comparison of 18F-FAPI-74 PET/CT to standard of care (SOC) imaging at up to 12 months after the initial scan at baseline and change from the baseline.
|
Baseline, 8-12 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Anthony F Suffredini, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10002534
- 002534-H
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