Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Location status: Recruiting
NCT Number: NCT06532071
The purpose of this study is to determine if measurements of active collagen deposition using [68Ga]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) and identify which individuals will develop progressive pulmonary fibrosis.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Boston, Massachusetts, 02114, United States
Location status: Recruiting
60 participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) on stable dose immunosuppression treatment will be enrolled. Participants will undergo combined [68Ga]CBP8 positron emission tomography (PET) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at baseline. The investigators will compare the ability of PET and MRI measurements performed over the whole lung and within regions of interest to identify participants who subsequently develop progressive pulmonary fibrosis as determined by changes in pulmonary function testing, quantitative fibrosis on high-resolution computed tomography, and respiratory symptoms over 24 months. The investigators will also test whether combining the PET and MRI measurements results in more accurate prediction of progression than either modality alone.
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
Other names: Dotarem
Time frame: Up to 24 months
Defined by the 2022 ATS guideline definition of progressive pulmonary fibrosis (PPF) which defines PPF as satisfying 2 of 3 criteria within 12 months: worsening symptoms, physiologic progression (absolute decline in FVC ≥ 5% or absolute decline in DLCO ≥ 10%), or radiologic evidence of disease progression.
Time frame: Up to 24 months
FVC will be measured at baseline, 6, 12, 18, and 24 months
Time frame: Up to 24 months
FVC will be measured at baseline, 6, 12, 18, and 24 months
Time frame: Up to 24 months
DLCO will be measured at baseline, 6, 12, 18, and 24 months
Contact information is provided by the study sponsor or research team.
Caroline Fromson
CONTACT
Sydney Montesi, MD
CONTACT
Peter Caravan
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT00001532
Asthma, Bronchial Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT07572383
Fibrosis, Interstitial Lung Disease
Boston, Massachusetts, United States
View Trial DetailsNCT05392881
Alveolitis, Extrinsic Allergic, Fibrosis
Kansas City, Kansas, United States
View Trial DetailsNCT06162884
Fibrosis, Lung Diseases
Los Angeles, California, United States
View Trial Details