Advanced Imaging for Pulmonary Fibrosis

NCT06532071 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024P001746
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Fibrosis

Outcome Measures

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.

  Up to 24 months

Secondary Outcomes (3)

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

  Up to 24 months

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

  Up to 24 months

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

  Up to 24 months

Study Arms (1)

Participants with Pulmonary Fibrosis

EXPERIMENTAL

Participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) will receive \[68Ga\]CBP8 and undergo PET combined with dynamic contrast-enhanced MRI

Drug: [68Ga]CBP8; Drug: Gadoterate Meglumine

Interventions

[68Ga]CBP8 DRUG

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

Participants with Pulmonary Fibrosis

Gadoterate Meglumine DRUG

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

Also known as: Dotarem

Participants with Pulmonary Fibrosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter Caravan: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

• Izquierdo-Garcia D, Desogere P, Fur ML, Shuvaev S, Zhou IY, Ramsay I, Lanuti M, Catalano OA, Catana C, Caravan P, Montesi SB. Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe. J Nucl Med. 2023 May;64(5):775-781. doi: 10.2967/jnumed.122.264530. Epub 2022 Dec 8.

  PMID: 37116909 BACKGROUND

• Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available.

  PMID: 31161770 BACKGROUND

• Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696.

  PMID: 28381537 BACKGROUND

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sydney Montesi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney Montesi, MD

CONTACT

617 724 4030; sbmontesi@mgb.org

Caroline Fromson

CONTACT

617 643 3260; cfromson@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)