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Regional Lung Imaging Using Hyperpolarized Xenon Gas

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ClinicalTrials.gov Identifier: NCT02112929
Recruitment Status : Unknown
Verified June 2016 by Fergus Gleeson, Oxford University Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : April 14, 2014
Last Update Posted : June 3, 2016
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University of Sheffield
Information provided by (Responsible Party):
Fergus Gleeson, Oxford University Hospitals NHS Trust

Brief Summary:
The investigators aim to use hyperpolarized xenon gas magnetic resonance imaging (MRI) and computed tomography to develop a new technique capable of objectively and quantitatively describing regional and structural lung abnormality. Since this is a relatively novel technique, the investigators first need to acquire imaging and clinical data from a group of participants with normal lungs. The investigators hope to generate an "atlas" of normality, which will form the foundation of future studies to compare with patients suffering from chronic respiratory disease. The investigators also aim to validate the new technique in terms of intra-subject reproducibility.

Condition or disease Intervention/treatment Phase
Lung Disease Drug: Hyperpolarized xenon Phase 1

Detailed Description:

Currently, the gold standard for assessment of lung function in chronic respiratory disease is spirometry. This is combined with anatomical imaging (chest x-ray and computed tomography) for structural assessment. Spirometry only measures global lung function. It provides no information regarding the different regions of the lung or about the supporting "framework" of the lung itself, the parenchyma. In addition, changes in lung function as measured with spirometric indices do not correlate coherently with the symptoms experienced by patients, nor reflect their decline in health. This weak relationship is probably because the lung is a complex regional organ where localized disturbances of a variety of factors including gas flow (ventilation), blood flow (perfusion) and gas transfer all combine to impair respiratory function.

MRI has the advantage of being an imaging technique free from ionizing radiation making it safe and practical for diseases such as asthma and obstructive lung disease where repeated follow-up scans are necessary. Hyperpolarized xenon, in the doses given for imaging has been shown to be safe. Conventional MRI has limited use in respiratory disease, because the lung is largely composed of air spaces that do not generate an MR signal. Hyperpolarized noble gases can resolve this problem.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Regional Lung Imaging and Modelling to Quantify Anatomy, Ventilation and Perfusion Using Hyperpolarized Xenon Gas MR and Thoracic CT Imaging
Study Start Date : April 2012
Estimated Primary Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Arm Intervention/treatment
Experimental: Inhalation of hyperpolarized xenon
One litre of hyperpolarized xenon to be inhaled during MRI scan of the lungs
Drug: Hyperpolarized xenon
Inhalation of up to one litre of polarized xenon gas, up to four inhalations per day are permitted.




Primary Outcome Measures :
  1. Imaging parameters from MRI scan after inhalation of hyperpolarized xenon gas [ Time Frame: Up to one year after first scan ]
    Maps of Apparent Diffusion Coefficient and objective measures of regional lung Production of Xe-129 ADC maps co-registered to CT and objective measures of regional lung anatomy, ventilation and perfusion in normals with hyperpolarized Xe-129 MR imaging (ADC quantification in cm2s-1). Derivation of reproducibility data


Secondary Outcome Measures :
  1. To produce and confirm reliability of maps to show regional blood perfusion in the lung area [ Time Frame: On entry to the study and one year later ]
    Maps of the dissolved fraction of Xe-129 to show hyperpolarized xenon transferred from the lungs to the blood

  2. Repeatability of the 129-Xe MR scans [ Time Frame: On study entry and one year later ]
    Compare scans on the same day with the patient prone and supine. Compare scans taken supine one year apart



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male, aged > 18 years.
  • Patients with previous histologically verified testicular germ cell tumour who have successfully undergone resection and do not and have never had metastatic disease.
  • Normal chest CT, confirmed subjectively by a Consultant Thoracic radiologist (Dr F. Gleeson or R. Benamore or their nominated representative), and no evidence of emphysema on CT density mapping to have been performed no more than one year prior to proposed hyperpolarized Xe-129 MR scan.
  • Normal spirometry indices (>80% predicted FEV1 [forced expiratory volume in one second]for age and height) and normal arterial oxygen saturations (SaO2), normal carbon monoxide transfer factor, and generally in good health with no subjective exercise limitation.
  • Current non-smokers with no significant smoking history (≤10 pack years) and no history of respiratory disease.
  • WHO performance status 0.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

  • Inability to give written informed consent.
  • Patients with a history of nodal or metastatic germ cell tumour.
  • Patients with a prior history of chemotherapy or radiotherapy at study entry.
  • Prior history of thoracic surgery or significant chest trauma
  • Prior history of significant smoking or respiratory disease.
  • The presence of another malignancy, where the extent of disease or treatment for that condition may interfere with the study endpoints.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Inability to lie flat for imaging.
  • Contra-indications to receiving iodine-based contrast during thoracic CT - those with marked renal failure not on dialysis, known allergy to contrast medium, history of anaphylaxis, known or suspected thyroid carcinoma and inability to gain intra-venous access.
  • Contraindications to MRI examination including indwelling pacemaker, non-MRI compatible metallic implant, severe claustrophobia, intra-ocular foreign body.
  • Epilepsy requiring on-going medical treatment, or a seizure within the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112929


Locations
United Kingdom
Oxford University Hospitals NHS Trust Recruiting
Oxford, England, United Kingdom, OX3 7LE
Contact: Jennifer M Lee       jenni.lee@ouh.nhs.uk   
Principal Investigator: Fergus V Gleeson         
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
National Institute for Health Research, United Kingdom
University of Sheffield
Investigators
Principal Investigator: Fergus V Gleeson Oxford University Hospitals NHS Trust

Responsible Party: Fergus Gleeson, Professor Of Radiology, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02112929     History of Changes
Other Study ID Numbers: HPX-2011-001
2011-002027-17 ( EudraCT Number )
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016

Keywords provided by Fergus Gleeson, Oxford University Hospitals NHS Trust:
Magnetic Resonance Imaging
Lung Diseases

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs