Recruiting
Phase 2

Imaging

Sponsor:

Massachusetts General Hospital

Code:

NCT05417776

Conditions

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

[68Ga]CBP8

Dotarem

Study Details

Brief summary:

The goal of this study is to investigate the ability of \[68Ga\]CBP8 to detect collagen deposition in early interstitial lung disease.

Conditions

Interstitial Lung Disease

Study ID

NCT05417776

Start date

Sep 28, 2022

Status verified date

Apr, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8)

  • Age greater than 40 years
  • Have the ability to give written informed consent
  • First degree relative of a family member with pulmonary fibrosis
  • No known history of interstitial lung disease
  • No tobacco use within the prior 6 months.

Group 2: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) (n=22)

  • Age greater than 40 years
  • Have the ability to give written informed consent
  • ILAs or early ILD (defined by presence of reticular markings and / or traction bronchiectasis but absence of a definite UIP pattern)
  • No tobacco use within the prior 6 months.

Exclusion criteria:

  • Electrical implants such as cardiac pacemaker or perfusion pump
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
  • Historical eGFR of less than 30 mL/min/1.73 m2
  • Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate)
  • Claustrophobic reactions
  • Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months)
  • Unable to lie comfortably on a bed inside the MR-PET
  • BMI > 33 (limit of the PET-MRI table)
  • Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures)
  • Pneumonia or other acute respiratory illness within 6 weeks of study entry
  • Parenchymal lung disease except for ILD/ILAs or emphysema
  • Acute exacerbation of ILD within the prior 6 months
  • VATS within the prior 6 months
  • Prior radiation therapy to the thorax
  • Known allergy to gadolinium.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)

Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive \[68Ga\]CBP8 and undergo PET-MRI.

experimental: First degree relatives of a family member with pulmonary fibrosis

First degree relatives of a family member with pulmonary fibrosis will receive \[68Ga\]CBP8 and undergo PET-MRI.

Interventions

[68Ga]CBP8

An injection of up to 350 MBq of \[68Ga\]CBP8 will be administered intravenously followed by PET-MRI.

Dotarem

Dotarem will be administered during MRI portion of study.

Primary outcome measure

  • Degree of uptake of [68Ga]CBP8 [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Sydney Montesi, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-20.