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
ID06532071
Advanced Imaging for Pulmonary Fibrosis
Led by Peter Caravan · Updated on 2026-04-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) to see if special imaging tests can predict how quickly their lung disease will get worse. The study focuses on measuring collagen buildup and tissue damage in the lungs using two imaging methods: [68Ga]CBP8 positron emission tomography (PET) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). The goal is to identify which patients will develop progressive pulmonary fibrosis over time. The study involves 60 participants who are on stable immunosuppressive medication. Each participant will receive a single intravenous injection of [68Ga]CBP8 and gadoterate meglumine during imaging. They will undergo combined PET and DCE-MRI scans at the start of the study. Researchers will compare the results of these scans to see if they can better predict disease progression when combined versus each alone. Participants will be followed for up to 24 months, with researchers monitoring lung function through pulmonary function tests and high-resolution CT scans, as well as respiratory symptoms. The main measurement is development of progressive pulmonary fibrosis. Secondary measures include declines in lung capacity tests. This study aims to improve understanding of disease progression using advanced imaging techniques.
CONDITIONS
Brief Title
Advanced Imaging for Pulmonary Fibrosis
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated interstitial lung disease (due to rheumatoid arthritis, systemic sclerosis, or mixed connective tissue disease), or undifferentiated interstitial lung disease
- On stable dose immunosuppression treatment (prednisone, mycophenolate mofetil, mycophenolate sodium, and/or rituximab) for at least 3 months
- Evidence of pulmonary fibrosis on high-resolution CT scan within 1 year or at baseline visit
- Forced vital capacity (FVC) of 45% or greater predicted and diffusing capacity for carbon monoxide (DLCO) of 25% or greater predicted at baseline
You will not qualify if you...
- Current or prior use of FDA approved anti-fibrotic therapy
- Extent of emphysema greater than extent of fibrosis
- Pregnancy or plans to become pregnant at baseline or during follow-up
- Contraindications to MRI
- Contraindications to gadolinium-based contrast agents
- Research-related radiation exposure exceeding 50 mSv in the past year
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min in individuals with chronic kidney disease
- Clinically significant pulmonary hypertension requiring pulmonary vasodilator therapy
- Respiratory infection within the prior 6 weeks
- Smoking of any kind within the prior 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.
Diagnostic Evaluation
Duration - 1 day
Participants receive a single intravenous injection of [68Ga]CBP8 and gadoterate meglumine and undergo combined PET and dynamic contrast-enhanced MRI imaging at baseline.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 24 months
Participants are monitored for up to 24 months to observe changes in pulmonary function, fibrosis progression, and respiratory symptoms.
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