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/37116909/Actively Recruiting
Led by Peter Caravan · Updated on 2026-07-14
15
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating how immunosuppression treatment affects lung fibrosis in adults with non-idiopathic pulmonary fibrosis interstitial lung disease non-IPF ILD. This phase 2 study aims to assess changes in active collagen deposition and tissue injury by using advanced imaging techniques, including 68GaCBP8 positron emission tomography PET and dynamic contrast-enhanced magnetic resonance imaging DCE-MRI. Fifteen participants diagnosed with non-IPF ILD, who are starting immunosuppression treatment, will receive a single intravenous injection of 68GaCBP8 and gadoterate meglumine during imaging. They will undergo PET and DCE-MRI scans before treatment and again 12 weeks after treatment initiation to evaluate the effects of immunosuppression on lung fibrosis. Throughout the study, participants will be closely monitored with imaging assessments at baseline and at 12 weeks to measure changes in lung tissue characteristics. Researchers will evaluate primary outcomes such as changes in maximum standardized uptake value SUVmax25 and contrast wash-in rate over the lungs. Secondary outcomes include various imaging parameters assessing lung function. The study will continue until December 2028, with all safety and imaging data collected during the 12-week follow-up.
CONDITIONS
Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis
S
Sydney Montesi, MD
C
Caroline Fromson
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Peter Caravan
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Investigational PET + MRI | Standard HRCT imaging |
|---|---|---|
| What it is | A combined investigational imaging technique using a collagen‑targeted PET tracer ([68Ga]CBP8) and dynamic contrast‑enhanced MRI with gadoterate meglumine to assess pulmonary fibrosis activity during immunosuppression | High‑resolution chest CT is the established imaging method used to diagnose and monitor fibrotic features such as honeycombing, reticulation, and traction bronchiectasis in ILD |
| Role in study | Used as the trial’s primary imaging method to quantify fibrosis activity and monitor changes over 12 weeks | Represents the conventional method against which new imaging tools are compared in clinical practice |
| Primary use | To measure changes in fibrosis‑related imaging biomarkers (SUVmax25, contrast wash‑in rate) over 12 weeks under immunosuppression | To provide anatomical imaging of lung fibrosis pattern and extent for diagnosis and serial monitoring |
| How it is performed | Participants undergo a single intravenous injection of [68Ga]CBP8 and an intravenous gadoterate meglumine contrast dose during DCE‑MRI, with imaging at baseline and again at 12 weeks | High‑resolution chest CT performed using thin‑section imaging without the investigational PET/MRI protocol |
| Evidence status | Early‑phase trial will generate data on PET/MRI biomarker changes but efficacy for disease monitoring is not yet established | HRCT impression correlates with fibrosis and progression, with established diagnostic and prognostic value in ILD |
| Important risks | Exposes participants to ionizing radiation from PET tracer and gadolinium contrast risks | Involves ionizing radiation exposure but no PET tracer or MRI contrast risks |
| Important limitations | Novel PET/MRI biomarkers require validation of clinical relevance and reproducibility; small single‑group design limits comparison to current care | HRCT assessment is qualitative and may lack sensitivity to early or subtle fibrotic changes compared to functional or molecular imaging |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants undergo PET and MRI scans before starting immunosuppression treatment and again 12 weeks after treatment begins to assess changes in lung fibrosis.
2 visits (baseline and 12 weeks post-treatment)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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David Izquierdo-Garcia, Pauline Désogère, Mariane Le Fur...
https://pubmed.ncbi.nlm.nih.gov/37116909/Sydney B Montesi, David Izquierdo-Garcia, Pauline Désogère...
https://pubmed.ncbi.nlm.nih.gov/31161770/Pauline Désogère, Luis F Tapias, Lida P Hariri...
https://pubmed.ncbi.nlm.nih.gov/28381537/Peter Caravan
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor