Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06532071

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 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Caroline Fromson

CONTACT

[email protected]

617 643 3260

Sydney Montesi, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, mycophenolate sodium, and/or rituximab) for at least 3 months.
  • Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.
  • FVC of >/= 45% and DLCO >/= 25% predicted on PFTs performed at Visit 1.

Exclusion criteria

  • 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 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 PH defined by use of pulmonary vasodilatory therapy.
  • Respiratory infection within the prior 6 weeks.
  • Smoking of any kind within the prior 6 months.

Treatment and study plan

[68Ga]CBP8

Drug

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

Gadoterate meglumine

Drug

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

Other names: Dotarem

Primary outcomes

  1. Development of progressive pulmonary fibrosis

    Time frame: Up to 24 months

    Defined by the 2022 ATS guideline definition of progressive pulmonary fibrosis (PPF) which defines PPF as satisfying 2 of 3 criteria within 12 months: worsening symptoms, physiologic progression (absolute decline in FVC ≥ 5% or absolute decline in DLCO ≥ 10%), or radiologic evidence of disease progression.

Secondary outcomes

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

    Time frame: Up to 24 months

    FVC will be measured at baseline, 6, 12, 18, and 24 months

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

    Time frame: Up to 24 months

    FVC will be measured at baseline, 6, 12, 18, and 24 months

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

    Time frame: Up to 24 months

    DLCO will be measured at baseline, 6, 12, 18, and 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Fromson

CONTACT

[email protected]

617 643 3260

Sydney Montesi, MD

CONTACT

[email protected]

617 724 4030

Sponsors and collaborators

Lead sponsor

Peter Caravan

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.