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Advanced Imaging for Pulmonary Fibrosis

Phase 2

Recruiting

Led By Sydney Montesi, MD

Research Sponsored by Peter Caravan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a combination of imaging techniques can help predict how quickly a patient's lung disease will progress and identify who is at risk of developing severe lung fibrosis.

Who is the study for?

This trial is for adults aged 18-80 with certain types of lung scarring diseases, like chronic hypersensitivity pneumonitis or connective tissue-associated ILD. They must have been on a stable immunosuppression treatment for at least 3 months and diagnosed within the last 5 years. Their lungs should function at a minimum level as measured by specific breathing tests.

What is being tested?

The study is testing two advanced imaging techniques: PET scans using [68Ga]CBP8 to measure collagen in the lungs, and DCE-MRI to assess lung injury. The goal is to see if these can predict how fast the disease will progress in patients with non-idiopathic pulmonary fibrosis.

What are the potential side effects?

Possible side effects from Gadoterate Meglumine (used in MRI) include headache, nausea, dizziness, or allergic reactions. The PET scan agent [68Ga]CBP8 may cause similar reactions but also carries risks associated with radiation exposure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Development of progressive pulmonary fibrosis

Secondary study objectives

Decline of diffusing capacity for carbon monoxide (DLCO) ≥15% from baseline

Decline of forced vital capacity (FVC) ≥ 5% from baseline

Decline of forced vital capacity (FVC) ≥10% from baseline

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Pulmonary FibrosisExperimental Treatment2 Interventions

Participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) will receive \[68Ga\]CBP8 and undergo PET combined with dynamic contrast-enhanced MRI

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gadoterate Meglumine

2012

N/A

~30

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