NCT07572383

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
33mo left

Started Apr 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2028

Study Start

First participant enrolled

April 1, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

April 17, 2026

Last Update Submit

May 2, 2026

Conditions

Interstitial Lung DiseasePulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

  • 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.

    From baseline to 12 weeks

  • 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.

    From baseline to 12 weeks

Secondary Outcomes (6)

  • Change in SUVmean over the entire lungs

    From baseline to 12 weeks

  • Change in SUVmax over the entire lungs

    From baseline to 12 weeks

  • Change in peak enhancement over the entire lungs

    From baseline to 12 weeks

  • Change in time to peak over the entire lungs

    From baseline to 12 weeks

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

    From baseline to 12 weeks

  • +1 more secondary outcomes

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 prior to and 12 weeks after starting clinically-prescribed immunosuppression for treatment of non-IPF ILD

Drug: [68Ga]CBP8Drug: Gadoterate Meglumine

Interventions

[68Ga]CBP8DRUG

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

Participants with Pulmonary Fibrosis
Gadoterate MeglumineDRUG

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

Participants with Pulmonary Fibrosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • 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.

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 37116909BACKGROUND

  • 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: 31161770BACKGROUND

  • 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: 28381537BACKGROUND

MeSH Terms

Conditions

Lung Diseases, InterstitialPulmonary Fibrosis

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sydney Montesi, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney Montesi, MD

CONTACT

617 724 4030sbmontesi@mgb.org

Caroline Fromson

CONTACT

617 643 3260cfromson@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
Sponsor

Study Record Dates

First Submitted

April 17, 2026

First Posted

May 7, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations

US(1)