Functional MR Lung Imaging Using Hyperpolarised 129Xe

Completed

• Conditions: IPF; COPD
• Interventions: Other: hyperpolarised 129 Xenon

• Registration Number: NCT02976935
• Lead Sponsor: University of Nottingham

Brief Summary

The aim of this study is to investigate the potential value of a novel imaging technique (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in patients with COPD and IPF.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-11-24
• Study First Posted: 2016-11-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	hyperpolarised 129 Xenon	Subjects will receive 1L non-hyperpolarised 129Xenon to inhale. Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath while the MRI scan is performed. Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L). Optional Study Visit #2:Identical to Study Visit 1 but with the further series of inhalations being up to a maximum of 4 (maximum total exposure to hyperpolarised 129Xenon will be 5L).Optional Study Visit #3: Identical to Study Visit 2 (maximum total exposure to hyperpolarised 129Xenon will be 5L)
Chronic Obstructive Pulmonary Disease	hyperpolarised 129 Xenon	Subjects will receive 1L bag of non-hyperpolarised 129Xenon to inhale. Then:Subjects will inhale the first hyperpolarised 129Xenon calibration dose (up to 1L, which may be a mix of hyperpolarised 129Xenon and N2) and hold their breath for required time while the MRI scan is performed.Then:A further series of inhalations will be performed up to a maximum of 3 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L). Optional Study Visit #2: Identical to Study Visit 1 (maximum total exposure to hyperpolarised 129Xenon will be 3.6L)

Primary Outcome Measures

Name	Time	Method
Acquisition of baseline data and images to investigate use of hp129Xe as a diagnostic tool	4 years	i) Obtain baseline data for each group with matched clinical data (e.g. pulmonary function tests) allowing comparison with existing clinical diagnostic techniques and also determining correlation with disease severity ii) Use the images obtained to set up standard sequencing protocols and define algorithms and inform power calculations for subsequent studies

Secondary Outcome Measures

Name	Time	Method
Collation of data regarding ability of participants to adhere to the study protocol	4 years	1) To collate data regarding the ability of participants of each group to adhere to the protocol thus informing the study design of future trials.

Trial Locations

Locations (1)

Hyperpolarised Imaging Lung Facility, QMC, Uni of Nottingham; 🇬🇧 Nottingham, United Kingdom