NCT05417776

Collagen-targeted PET Imaging for Early Interstitial Lung Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to investigate the ability of \[68Ga\]CBP8 to detect collagen deposition in early interstitial lung disease.

Detailed description

\[68Ga\]CBP8, is a PET imaging probe which selectively binds collagen type I. Collagen deposition is a pivotal event in the development of pulmonary fibrosis. \[68Ga\]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles. \[68Ga\]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis and response to treatment. In addition, \[68Ga\]CBP8 can detect increased collagen in the lungs of patients with idiopathic pulmonary fibrosis. The goals of this study are: 1. To determine whether collagen deposition as assessed by \[68Ga\]CBP8-PET MRI can detect increased collagen deposition in early interstitial lung disease and 2. if the degree of \[68Ga\]CBP8 uptake predicts subsequent disease progression.

Conditions

• Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	[68Ga]CBP8	An injection of up to 350 MBq of \[68Ga\]CBP8 will be administered intravenously followed by PET-MRI.
DRUG	Dotarem	Dotarem will be administered during MRI portion of study.

Timeline

• Start date: 2022-09-28
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2022-06-14
• Last updated: 2025-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study