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RecruitingPhase 2NCT07572383

Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis

Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Lung Fibrosis in Participants With Non-Idiopathic Pulmonary Fibrosis Interstitial Lung Disease

Sponsor

Peter Caravan

Enrollment

15 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Interstitial Lung DiseasePulmonary Fibrosis

Summary

The purpose of this study is to investigate how immunosuppression treatment affects measurements of active collagen deposition using \[68Ga\]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in individuals with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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.
  • Starting immunosuppression treatment with mycophenolate mofetil, mycophenolate sodium, and / or prednisone for clinically indicated non-IPF ILD treatment.
  • Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on high-resolution computed tomography (HRCT) performed within 1 year to or at Visit 1.
  • Forced vital capacity (FVC) of >/= 45% and diffusing capacity of the lungs for carbon monoxide (DLCO) >/= 25% predicted on PFTs performed at Visit 1.

Exclusion Criteria10

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

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Interventions

DRUG[68Ga]CBP8

Participants will receive a single intravenous injection of up to 350 MBq of \[68Ga\]CBP8

DRUGGadoterate Meglumine

Participants will receive a single intravenous injection of 0.05 mmol/kg gadoterate meglumine during DCE-MRI

Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT07572383

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