Recruiting
Phase 2

Immunosuppression Treatment

Sponsor:

Peter Caravan

Code:

NCT07572383

Conditions

Interstitial Lung Disease

Pulmonary Fibrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

[68Ga]CBP8

Gadoterate Meglumine

Study Details

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).

Conditions

Interstitial Lung Disease

Pulmonary Fibrosis

Study ID

NCT07572383

Start date

May 14, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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. Starting immunosuppression treatment with mycophenolate mofetil, mycophenolate sodium, and / or prednisone for clinically indicated non-IPF ILD treatment.
3. 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.
4. Forced vital capacity (FVC) of >/= 45% and diffusing capacity of the lungs for carbon monoxide (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 millisievert (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 pulmonary hypertension (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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

[68Ga]CBP8

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

Gadoterate Meglumine

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

Primary outcome measure

  • Change in SUVmax25 over the entire lungs [ Time Frame: From baseline to 12 weeks ]
  • Change in the rate of contrast washin (kwashin) over the entire lungs [ Time Frame: From baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Sydney Montesi, MD

More Information

Sponsor

Peter Caravan

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Peter Caravan on 2026-07-14.