Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Location status: Recruiting
NCT Number: NCT07572383
The purpose of this study is to investigate how immunosuppression treatment affects measurements of active collagen deposition using [68Ga]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in individuals with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD).
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Boston, Massachusetts, 02114, United States
Location status: Recruiting
15 different subjects with non-IPF ILD starting immunosuppression treatment for their underlying ILD will be enrolled. Participants will undergo [68Ga]CBP8 PET and DCE-MRI prior to and 12 weeks after treatment initiation to determine the effects of immunosuppressive treatment on PET measurements of collagen deposition and selected DCE-MRI-derived measurements.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single intravenous injection of up to 350 MBq of [68Ga]CBP8
Participants will receive a single intravenous injection of 0.05 mmol/kg gadoterate meglumine during DCE-MRI
Time frame: From baseline to 12 weeks
Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the mean of the upper quartile of standardized uptake values (SUVmax25). Primary [68Ga]CBP8-PET outcome.
Time frame: From baseline to 12 weeks
Changes in rate of contrast washin will be measured using dynamic-contrast enhanced MRI. Primary DCE-MRI outcomes.
Time frame: From baseline to 12 weeks
Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the mean standardized uptake value (SUVmean).
Time frame: From baseline to 12 weeks
Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the max standardized uptake value (SUVmax).
Time frame: From baseline to 12 weeks
Changes in peak enhancement will be measured using dynamic-contrast enhanced MRI
Time frame: From baseline to 12 weeks
Changes in time to peak will be measured using dynamic-contrast enhanced MRI
Time frame: From baseline to 12 weeks
Changes in the area under the curve at 60 seconds will be measured using dynamic-contrast enhanced MRI
Time frame: From baseline to 12 weeks
Changes in the rate of contrast washout will be measured using dynamic-contrast enhanced MRI.
Contact information is provided by the study sponsor or research team.
Caroline Fromson
CONTACT
Sydney Montesi, MD
CONTACT
Peter Caravan
Other
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Lung Fibrosis in Participants With Non-Idiopathic Pulmonary Fibrosis Interstitial Lung Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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