Purpose

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

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: [68Ga]CBP8
    An injection of up to 350 MBq of [68Ga]CBP8 will be administered intravenously followed by PET-MRI.
  • Drug: Dotarem
    Dotarem will be administered during MRI portion of study.
    Other names:
    • gadoterate meglumine
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.
  • Drug: [68Ga]CBP8
    An injection of up to 350 MBq of [68Ga]CBP8 will be administered intravenously followed by PET-MRI.
  • Drug: Dotarem
    Dotarem will be administered during MRI portion of study.
    Other names:
    • gadoterate meglumine

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Abimbola Akinniyi

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Sydney B Montesi, MD
617-724-4030
sbmontesi@partners.org

Detailed Description

[68Ga]CBP8, is a PET imaging probe which selectively binds collagen type I. Collagen deposition is a pivotal event in the development of pulmonary fibrosis. [68Ga]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles. [68Ga]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis and response to treatment. In addition, [68Ga]CBP8 can detect increased collagen in the lungs of patients with idiopathic pulmonary fibrosis. The goals of this study are: 1. To determine whether collagen deposition as assessed by [68Ga]CBP8-PET MRI can detect increased collagen deposition in early interstitial lung disease and 2. if the degree of [68Ga]CBP8 uptake predicts subsequent disease progression.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.