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Completed

NCT Number: NCT02976935

Functional MR Lung Imaging Using Hyperpolarised 129Xe

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hyperpolarised Imaging Lung Facility, QMC, Uni of Nottingham

Nottingham, NG7 2UH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyperpolarised 129 Xenon

Other

Hyperpolarised 129 Xe to assess lung function

Primary outcomes

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

    Time frame: 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 outcomes

  1. Collation of data regarding ability of participants to adhere to the study protocol

    Time frame: 4 years

    • To collate data regarding the ability of participants of each group to adhere to the protocol thus informing the study design of future trials.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

FUNCTIONAL MAGNETIC RESONANCE LUNG IMAGING USING INHALED HYPERPOLARISED 129Xe

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Nov 30, 2016
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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