Functional MR Lung Imaging Using Hyperpolarised 129Xe

NCT02976935 | Completed

• 1 other identifier: 13104
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; IPF

Outcome Measures

Primary Outcomes (1)

• Acquisition of baseline data and images to investigate use of hp129Xe as a diagnostic tool

  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

  4 years

Secondary Outcomes (1)

• Collation of data regarding ability of participants to adhere to the study protocol

  4 years

Study Arms (2)

Healthy Volunteers

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)

Other: hyperpolarised 129 Xenon

Chronic Obstructive Pulmonary Disease

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)

Other: hyperpolarised 129 Xenon

Interventions

hyperpolarised 129 Xenon OTHER

Hyperpolarised 129 Xe to assess lung function

Chronic Obstructive Pulmonary Disease; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers, COPD

You may qualify if:

• Male or Female aged over 18 years.
• Capacity to give informed consent
• Normal blood pressure (systolic BP \> 100 mmHg and diastolic BP \> 70 mmHg)
• Resting heart rate \> 50 bpm
• For women, negative urinary β-hCG at the screening and subsequent visits
• Subject able to hold breath for 10 seconds
• Subject able to fit into 129Xe chest coil used for MRI
• Subject able to understand the requirements of the study and to cooperate with the study procedures
• HEALTHY VOLUNTEERS
• No significant respiratory disease within the last year
• PATIENTS
• COPD
• Evidence of airflow obstruction (FEV/FVC \<0.7) and FEV1 \<80% predicted post bronchodilator
• Minimum FVC 1.5L

You may not qualify if:

• HEALTHY VOLUNTEERS
• Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
• Acute respiratory illness within 30 days of MRI
• Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
• Subject deemed unlikely to comply with instructions during imaging
• Subject not deemed fit enough to tolerate procedure
• Subject deemed unsuitable by clinical investigator for other reasons
• PATIENTS
• Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
• Acute respiratory illness within 30 days of MRI
• Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
• Subject deemed unlikely to comply with instructions during imaging
• Subject not deemed fit enough to tolerate procedure
• Subject deemed unsuitable by clinical investigator for other reasons

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Hyperpolarised Imaging Lung Facility, QMC, Uni of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: November 30, 2016
• Study Start: February 1, 2014
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

GB (1)