Functional MR Lung Imaging Using Hyperpolarised 129Xe

COPD Clinical Trial

Official title:

FUNCTIONAL MAGNETIC RESONANCE LUNG IMAGING USING INHALED HYPERPOLARISED 129Xe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976935
• Other study ID #: 13104
• Status: Completed
• Start date: February 2014
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

General Inclusion criteria

• 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 ß-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

Inclusion criteria

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

Exclusion criteria

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

• Do not meet the inclusion criteria above

• 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

• Do not meet the inclusion criteria above

• Subject not deemed fit enough to tolerate procedure

• Subject deemed unsuitable by clinical investigator for other reasons

Related Conditions & MeSH terms

• COPD
• IPF

Intervention

Other:
• hyperpolarised 129 Xenon
Hyperpolarised 129 Xe to assess lung function

Locations

Country	Name	City	State
United Kingdom	Hyperpolarised Imaging Lung Facility, QMC, Uni of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Collation of data regarding ability of participants to adhere to the study protocol	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.	4 years