Interstitial Lung Disease, Pulmonary Fibrosis
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUG[68Ga]CBP8
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
Sponsors
Peter Caravan
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ILD. 2. Starting immunosuppression treatment with mycophenolate mofetil, mycophenolate sodium, and / or prednisone for clinically indicated non-IPF ILD treatment. 3. Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on high-resolution computed tomography (HRCT) performed within 1 year to or at Visit 1. 4. Forced vital capacity (FVC) of \>/= 45% and diffusing capacity of the lungs for carbon monoxide (DLCO) \>/= 25% predicted on PFTs performed at Visit 1.
Exclusion criteria
1. Current or prior exposure to FDA approved anti-fibrotic therapy. 2. Extent of emphysema greater than extent of fibrosis. 3. Pregnancy or plans to become pregnant at baseline or during follow-up. 4. Contraindications to MRI. 5. Contraindications to receiving gadolinium-based contrast agents. 6. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior year. 7. Estimated glomerular filtration rate (eGFR) \< 30 mL/min (only for individuals with a history of chronic kidney disease). 8. Clinically significant pulmonary hypertension (PH) defined by use of pulmonary vasodilatory therapy. 9. Respiratory infection within the prior 6 weeks. 10. Smoking of any kind within the prior 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SUVmax25 over the entire lungs | 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. |
| Change in the rate of contrast washin (kwashin) over the entire lungs | From baseline to 12 weeks | Changes in rate of contrast washin will be measured using dynamic-contrast enhanced MRI. Primary DCE-MRI outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SUVmean over the entire lungs | 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). |
| Change in SUVmax over the entire lungs | 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). |
| Change in peak enhancement over the entire lungs | From baseline to 12 weeks | Changes in peak enhancement will be measured using dynamic-contrast enhanced MRI |
| Change in time to peak over the entire lungs | From baseline to 12 weeks | Changes in time to peak will be measured using dynamic-contrast enhanced MRI |
| Change in the area under the curve at 60 seconds (AUC60) over the entire lungs | From baseline to 12 weeks | Changes in the area under the curve at 60 seconds will be measured using dynamic-contrast enhanced MRI |
| Change in the rate of contrast washout (kwashout) over the entire lungs | From baseline to 12 weeks | Changes in the rate of contrast washout will be measured using dynamic-contrast enhanced MRI. |
Countries
United States
Contacts
CONTACTSydney Montesi, MD
CONTACTCaroline Fromson
PRINCIPAL_INVESTIGATORSydney Montesi, MD
Massachusetts General Hospital
Outcome results
None listed