Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Fibrosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Peter Caravan
Study ID
NCT07572383
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • [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

Study Details

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).

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

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

Primary Outcome Measure

Change in SUVmax25 over the entire lungs [ Time Frame: From baseline to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Sydney Montesi
617 643 3260
Sydney Montesi, MD (PRINCIPAL_INVESTIGATOR)

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