Functional MR Lung Imaging Using Hyperpolarised 129Xe

University of Nottingham

Status: Completed

Conditions: IPF; COPD

Treatments: Other: hyperpolarised 129 Xenon

Study type: Observational

Funder types: Other

Identifiers

NCT02976935

13104

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 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

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

Trial design

53 participants in 2 patient groups

Healthy Volunteers

Description:

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)

Treatment:

Other: hyperpolarised 129 Xenon

Chronic Obstructive Pulmonary Disease

Description:

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)

Treatment:

Other: hyperpolarised 129 Xenon