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Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis

ConditionsInterstitial Lung DiseasePulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeter Caravan

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • [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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Participants with Pulmonary FibrosisExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in SUVmax25 over the entire lungs

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.

Time frame
From baseline to 12 weeks
2

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

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

Time frame
From baseline to 12 weeks

Secondary outcomes

1

Change in SUVmean over the entire lungs

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).

Time frame
From baseline to 12 weeks
2

Change in SUVmax over the entire lungs

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).

Time frame
From baseline to 12 weeks
3

Change in peak enhancement over the entire lungs

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

Time frame
From baseline to 12 weeks
4

Change in time to peak over the entire lungs

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

Time frame
From baseline to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peter Caravan

Lead sponsor

Massachusetts General Hospital

Sponsor institution

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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