Advanced Imaging for Pulmonary Fibrosis

NCT ID: NCT06532071

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2028-12-31

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.

Detailed Description

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.

Conditions

Pulmonary Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Participants with Pulmonary Fibrosis

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

Group Type: EXPERIMENTAL

[68Ga]CBP8

Intervention Type: DRUG

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

Gadoterate Meglumine

Intervention Type: DRUG

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

Interventions

[68Ga]CBP8

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

Intervention Type: DRUG

Gadoterate Meglumine

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

Intervention Type: DRUG

Other Intervention Names

Dotarem

Eligibility Criteria

Inclusion Criteria

1. 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.

2. On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, and/or rituximab) for at least 3 months.

3. Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.

4. FVC of >/= 45% and DLCO >/= 25% predicted on PFTs performed at Visit 1.

Exclusion Criteria

1. Current or prior exposure to FDA approved anti-fibrotic therapy.

2. Extent of emphysema greater than extent of fibrosis.

3. Pregnancy or plans to become pregnant at baseline or during follow-up.

4. Contraindications to MRI.

5. Contraindications to receiving gadolinium-based contrast agents.

6. Research-related radiation exposure exceeds 50 mSv in the prior year.

7. Estimated glomerular filtration rate (eGFR) < 30 mL/min (only for individuals with a history of chronic kidney disease).

8. Clinically significant PH defined by use of pulmonary vasodilatory therapy.

9. Respiratory infection within the prior 6 weeks.

10. Smoking of any kind within the prior 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peter Caravan

OTHER

Sponsor Role: lead

Responsible Party

Peter Caravan

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sydney Montesi, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sydney Montesi, MD

Role: CONTACT

sbmontesi@mgb.org

617 724 4030

Ceanna Kalaria

Role: CONTACT

CKALARIA@mgh.harvard.edu

617 726 3520

Facility Contacts

Ceanna Kalaria

Role: primary

CKALARIA@mgh.harvard.edu

617 726 3520

References

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.

Reference Type: BACKGROUND

PMID: 37116909 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31161770 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28381537 (View on PubMed)

Other Identifiers

2024P001746

Identifier Type: -

Identifier Source: org_study_id