RecruitingPhase 2NCT05417776

Collagen-targeted PET Imaging for Early Interstitial Lung Disease

Sponsor

Massachusetts General Hospital

Enrollment

30 participants

Start Date

Sep 28, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 Years

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.

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.

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DRUG[68Ga]CBP8

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

DRUGDotarem

Dotarem will be administered during MRI portion of study.

Massachusetts General Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT05417776