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RECRUITINGPhase 2NCT06532071

Advanced Imaging for Pulmonary Fibrosis

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...

Lead sponsor: Peter Caravan•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Sydney Montesi, MD

CONTACT

617 724 4030 sbmontesi@mgb.org

Caroline Fromson

CONTACT

617 643 3260 cfromson@mgh.harvard.edu

Sponsors

Lead Sponsor

Peter Caravan

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.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ILD.
•2. On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, mycophenolate sodium, and/or rituximab) for at least 3 months.
•3. Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.
•4. FVC of \>/= 45% and DLCO \>/= 25% predicted on PFTs performed at Visit 1.

Exclusion Criteria

•1. Current or prior exposure to FDA approved anti-fibrotic therapy.
•2. Extent of emphysema greater than extent of fibrosis.
•3. Pregnancy or plans to become pregnant at baseline or during follow-up.
•4. Contraindications to MRI.
•5. Contraindications to receiving gadolinium-based contrast agents.
•6. Research-related radiation exposure exceeds 50 mSv in the prior year.
•7. Estimated glomerular filtration rate (eGFR) \< 30 mL/min (only for individuals with a history of chronic kidney disease).
•8. Clinically significant PH defined by use of pulmonary vasodilatory therapy.
•9. Respiratory infection within the prior 6 weeks.
•10. Smoking of any kind within the prior 6 months.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 22, 2026Terms

Trial snapshot

StatusRECRUITING

PhasePHASE2

Enrollment60

Start dateJan 2025

Last updatedApr 22, 2026

Condition

Pulmonary Fibrosis

Locations shown

Massachusetts General Hospital

Boston, Massachusetts

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2026Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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