NCT06532071

Advanced Imaging for Pulmonary Fibrosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peter Caravan · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if measurements of active collagen deposition using \[68Ga\]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) and identify which individuals will develop progressive pulmonary fibrosis.

Detailed description

60 participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) on stable dose immunosuppression treatment will be enrolled. Participants will undergo combined \[68Ga\]CBP8 positron emission tomography (PET) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at baseline. The investigators will compare the ability of PET and MRI measurements performed over the whole lung and within regions of interest to identify participants who subsequently develop progressive pulmonary fibrosis as determined by changes in pulmonary function testing, quantitative fibrosis on high-resolution computed tomography, and respiratory symptoms over 24 months. The investigators will also test whether combining the PET and MRI measurements results in more accurate prediction of progression than either modality alone.

Conditions

• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	[68Ga]CBP8	Participants will receive a single intravenous injection of up to 350 MBq of \[68Ga\]CBP8
DRUG	Gadoterate Meglumine	Participants will receive a single intravenous injection of 0.05 mmol/kg gadoterate meglumine during DCE-MRI

Timeline

• Start date: 2025-01-21
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2024-08-01
• Last updated: 2025-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study