Health TrialsbyHealthPanel

Advanced Imaging for Pulmonary Fibrosis

ConditionPulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeter Caravan

About this trial

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.

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.

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.

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

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

Trial outcomes

Primary outcomes

1

Development of progressive pulmonary fibrosis

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.

Time frame
Up to 24 months

Secondary outcomes

1

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

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

Time frame
Up to 24 months
2

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

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

Time frame
Up to 24 months
3

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

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

Time frame
Up to 24 months

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

Source ClinicalTrials.gov
Apply now