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 2026-04-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
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 68GaCBP8 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 68GaCBP8 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
Advanced Imaging for Pulmonary Fibrosis
S
Sydney Montesi, MD
C
Caroline Fromson
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Peter Caravan
Lead 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 | [68Ga]CBP8 PET Imaging | Current Standard Imaging |
|---|---|---|
| What it is | [68Ga]CBP8 PET imaging is an investigational nuclear medicine scan using a type I collagen-targeted PET probe, with an optional DCE-MRI and gadolinium-based contrast, to visualize active fibrotic tissue in the lungs. | Current standard imaging combines high-resolution computed tomography (HRCT), along with pulmonary function tests, to diagnose and assess the severity and progression of pulmonary fibrosis. |
| Role in study or care | Investigational diagnostic imaging to visualize and potentially quantify active lung fibrosis in patients meeting trial criteria. | Established diagnostic and monitoring approach for identifying, staging, and following patients with pulmonary fibrosis. |
| Primary use | To detect and assess the extent of active lung fibrosis using a type I collagen-targeted probe, aiming to improve disease monitoring beyond current imaging standards. | To diagnose pulmonary fibrosis, determine extent of fibrosis, and monitor changes over time through routine clinical imaging and functional testing. |
| How it is given or performed | Participants receive a single intravenous injection of [68Ga]CBP8 followed by PET imaging of the lungs. Dynamic contrast-enhanced MRI with gadolinium is also performed in the same session. | Standard care includes non-invasive HRCT scanning and pulmonary function tests; contrast MRI is not typically routine for fibrosis diagnosis but may be used in select cases. |
| Evidence status | Early human studies and preclinical evidence suggest [68Ga]CBP8 uptake correlates with the presence and severity of lung fibrosis. Performance and clinical utility in diverse populations require confirmation in larger trials. | HRCT and pulmonary function measures have longstanding validation and are accepted standards for diagnosing, assessing, and monitoring pulmonary fibrosis. |
| Important limitations | Clinical performance and added value to standard imaging are not yet established; access to PET imaging and radiotracers may be limited to research centers. | HRCT and standard functional tests cannot directly visualize active fibrotic activity; findings require interpretation and may not fully capture dynamic disease processes. |
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.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
Duration - Up to 24 months
Participants are monitored for up to 24 months to observe changes in pulmonary function, fibrosis progression, and respiratory symptoms.
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