Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe.
David Izquierdo-Garcia, Pauline Désogère, Mariane Le Fur...
https://pubmed.ncbi.nlm.nih.gov/37116909Actively Recruiting
Phase 2
Age: 18Years - 80Years
All Genders
ID07572383
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Lung Fibrosis in Participants With Non-Idiopathic Pulmonary Fibrosis Interstitial Lung Disease
Led by Peter Caravan · Updated on 2026-05-07
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Peter Caravan
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how immunosuppression treatment affects active collagen deposition and tissue injury in people with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD). This Phase 2 study uses advanced imaging techniques to measure changes in lung fibrosis and tissue damage. The study focuses on evaluating these effects in individuals starting immunosuppressive therapy for their lung condition. Participants will receive an intravenous injection of a radioactive tracer called [68Ga]CBP8 and a contrast agent named gadoterate meglumine for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). These imaging scans will be done before and 12 weeks after starting clinically prescribed immunosuppressive treatment, aiming to assess changes in collagen deposition and lung tissue injury. The treatment involves immunosuppressive drugs such as mycophenolate mofetil, mycophenolate sodium, and/or prednisone. During the study, 15 participants will undergo PET scans combined with DCE-MRI at two time points: before treatment and 12 weeks after beginning immunosuppression. Researchers will measure changes in lung imaging markers such as SUVmax25 and rates of contrast wash-in and wash-out to evaluate lung fibrosis progression. Safety and treatment effects will be monitored throughout the study, which is expected to last at least 12 weeks from treatment start.
CONDITIONS
Brief Title
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD, or undifferentiated ILD
- Starting immunosuppression treatment with mycophenolate mofetil, mycophenolate sodium, and/or prednisone for non-IPF ILD
- Evidence of pulmonary fibrosis on high-resolution CT within 1 year or at baseline
- Forced vital capacity (FVC) of at least 45% predicted and lung diffusing capacity (DLCO) of at least 25% predicted at baseline
You will not qualify if you...
- Current or prior use of FDA-approved anti-fibrotic therapy
- Extent of emphysema greater than fibrosis
- Pregnancy or plans to become pregnant at baseline or during follow-up
- Contraindications to MRI or gadolinium contrast agents
- Research-related radiation exposure over 50 mSv in the past year
- Estimated glomerular filtration rate (eGFR) below 30 mL/min in those with chronic kidney disease
- Clinically significant pulmonary hypertension requiring vasodilator therapy
- Respiratory infection within the past 6 weeks
- Smoking of any kind within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 week
Participants undergo advanced imaging including PET combined with dynamic contrast-enhanced MRI prior to starting immunosuppressive treatment to assess lung fibrosis.
1 visit (in-person) for imaging procedures
Treatment
Duration - 12 weeks
Participants start clinically-prescribed immunosuppressive treatment for non-IPF interstitial lung disease.
Treatment occurs as prescribed clinically; imaging assessments before and after treatment are scheduled separately
Diagnostic Evaluation
Duration - 1 week
Participants undergo repeat PET and dynamic contrast-enhanced MRI 12 weeks after starting immunosuppressive treatment to assess treatment effects.
1 visit (in-person) for follow-up imaging procedures
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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Research Team
S
Sydney Montesi, MD
C
Caroline Fromson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies.
Sydney B Montesi, David Izquierdo-Garcia, Pauline Désogère...
https://pubmed.ncbi.nlm.nih.gov/31161770Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models.
Pauline Désogère, Luis F Tapias, Lida P Hariri...
https://pubmed.ncbi.nlm.nih.gov/28381537