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NCT Number: NCT07572383

Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis

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).

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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

Sydney Montesi

CONTACT

[email protected]

617 643 3260

Sydney Montesi, MD

PRINCIPAL_INVESTIGATOR

About this study

15 different subjects with non-IPF ILD starting immunosuppression treatment for their underlying ILD will be enrolled. Participants will undergo [68Ga]CBP8 PET and DCE-MRI prior to and 12 weeks after treatment initiation to determine the effects of immunosuppressive treatment on PET measurements of collagen deposition and selected DCE-MRI-derived measurements.

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.
  • 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 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 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.

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

Primary outcomes

  1. Change in SUVmax25 over the entire lungs

    Time frame: From baseline to 12 weeks

    Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the mean of the upper quartile of standardized uptake values (SUVmax25). Primary [68Ga]CBP8-PET outcome.

  2. Change in the rate of contrast washin (kwashin) over the entire lungs

    Time frame: From baseline to 12 weeks

    Changes in rate of contrast washin will be measured using dynamic-contrast enhanced MRI. Primary DCE-MRI outcomes.

Secondary outcomes

  1. Change in SUVmean over the entire lungs

    Time frame: From baseline to 12 weeks

    Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the mean standardized uptake value (SUVmean).

  2. Change in SUVmax over the entire lungs

    Time frame: From baseline to 12 weeks

    Changes in lung collagen uptake will be measured using the PET probe [68]Ga-CBP8. Measurements will be made using the max standardized uptake value (SUVmax).

  3. Change in peak enhancement over the entire lungs

    Time frame: From baseline to 12 weeks

    Changes in peak enhancement will be measured using dynamic-contrast enhanced MRI

  4. Change in time to peak over the entire lungs

    Time frame: From baseline to 12 weeks

    Changes in time to peak will be measured using dynamic-contrast enhanced MRI

  5. Change in the area under the curve at 60 seconds (AUC60) over the entire lungs

    Time frame: From baseline to 12 weeks

    Changes in the area under the curve at 60 seconds will be measured using dynamic-contrast enhanced MRI

  6. Change in the rate of contrast washout (kwashout) over the entire lungs

    Time frame: From baseline to 12 weeks

    Changes in the rate of contrast washout will be measured using dynamic-contrast enhanced MRI.

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

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 7, 2026
Registry last updated
Jul 14, 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.

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