RECRUITING

Advanced Imaging for Pulmonary Fibrosis

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Conditions

Pulmonary Fibrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Advanced Imaging for Pulmonary Fibrosis

Quick Facts

Study Start:2024-11
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06532071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. ILD diagnosis within 5 years of Visit 1.
  3. 3. On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, and/or rituximab) for at least 3 months.
  4. 4. Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.
  5. 5. FVC of \>/= 45% and DLCO \>/= 25% predicted on PFTs performed at Visit 1.
  1. 1. Current or prior exposure to FDA approved anti-fibrotic therapy.
  2. 2. Extent of emphysema greater than extent of fibrosis.
  3. 3. Pregnancy or plans to become pregnant at baseline or during follow-up.
  4. 4. Contraindications to MRI.
  5. 5. Contraindications to receiving gadolinium-based contrast agents.
  6. 6. Research-related radiation exposure exceeds 50 mSv in the prior year.
  7. 7. Estimated glomerular filtration rate (eGFR) \< 30 mL/min (only for individuals with a history of chronic kidney disease).
  8. 8. Clinically significant PH defined by use of pulmonary vasodilatory therapy.
  9. 9. Respiratory infection within the prior 6 weeks.
  10. 10. Smoking of any kind within the prior 6 months.

Contacts and Locations

Study Contact

Sydney Montesi, MD
CONTACT
617 724 4030
sbmontesi@mgb.org
Ceanna Kalaria
CONTACT
617 726 3520
CKALARIA@mgh.harvard.edu

Principal Investigator

Sydney Montesi, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Peter Caravan

  • Sydney Montesi, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-11
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pulmonary Fibrosis