Clinical trial
Hyperpolarized 129Xe MR Imaging of the Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Name
Pro00025110
Description
The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC), and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding the normal resting heterogeneity of pulmonary gas exchange.
Trial arms
Trial start
2011-01-01
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Hyperpolarized 129Xenon Gas
Hyperpolarized 129Xenon Gas will be administered in multiple doses in volumes that are tailored to the subject's total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
Size
445
Primary endpoint
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Day 2
Eligibility criteria
Inclusion Criteria:
Inclusion Criteria for Healthy Control Subjects
1. Subject has no diagnosed pulmonary conditions
2. Subject has not smoked in the previous 5 years.
3. Smoking history, if any, is less than or equal to 5 pack-years.
Inclusion Criteria for Subjects with lung disease
1. Subject has a diagnosis of pulmonary dysfunction made by a physician
2. No acute worsening of pulmonary function in the past 30 days
Exclusion Criteria:
1. Subject is less than 18 years old
2. MRI is contraindicated based on responses to MRI screening questionaire
3. Subject is pregnant or lactating
4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
5. Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI
6. Subject has any form of known cardiac arrhythmia
7. Subject does not fit into 129Xe vest coil used for MRI
8. Subject cannot hold his/her breath for 15 seconds
9. Subject deemed unlikely to be able to comply with instructions during imaging
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 445, 'type': 'ESTIMATED'}}
Updated at
2024-01-17
1 organization
Organization
Bastiaan Driehuys