Regional Lung Imaging Using Hyperpolarized Xenon Gas
Primary Purpose
Lung Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Hyperpolarized xenon
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Disease focused on measuring Magnetic Resonance Imaging, Lung Diseases
Eligibility 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.
Sites / Locations
- Oxford University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inhalation of hyperpolarized xenon
Arm Description
One litre of hyperpolarized xenon to be inhaled during MRI scan of the lungs
Outcomes
Primary Outcome Measures
Imaging parameters from MRI scan after inhalation of hyperpolarized xenon gas
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
To produce and confirm reliability of maps to show regional blood perfusion in the lung area
Maps of the dissolved fraction of Xe-129 to show hyperpolarized xenon transferred from the lungs to the blood
Repeatability of the 129-Xe MR scans
Compare scans on the same day with the patient prone and supine. Compare scans taken supine one year apart
Full Information
NCT ID
NCT02112929
First Posted
July 10, 2012
Last Updated
February 7, 2022
Sponsor
Oxford University Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom, University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT02112929
Brief Title
Regional Lung Imaging Using Hyperpolarized Xenon Gas
Official Title
Regional Lung Imaging and Modelling to Quantify Anatomy, Ventilation and Perfusion Using Hyperpolarized Xenon Gas MR and Thoracic CT Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford University Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom, University of Sheffield
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
Magnetic Resonance Imaging, Lung Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhalation of hyperpolarized xenon
Arm Type
Experimental
Arm Description
One litre of hyperpolarized xenon to be inhaled during MRI scan of the lungs
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized xenon
Intervention Description
Inhalation of up to one litre of polarized xenon gas, up to four inhalations per day are permitted.
Primary Outcome Measure Information:
Title
Imaging parameters from MRI scan after inhalation of hyperpolarized xenon gas
Description
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
Time Frame
Up to one year after first scan
Secondary Outcome Measure Information:
Title
To produce and confirm reliability of maps to show regional blood perfusion in the lung area
Description
Maps of the dissolved fraction of Xe-129 to show hyperpolarized xenon transferred from the lungs to the blood
Time Frame
On entry to the study and one year later
Title
Repeatability of the 129-Xe MR scans
Description
Compare scans on the same day with the patient prone and supine. Compare scans taken supine one year apart
Time Frame
On study entry and one year later
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fergus V Gleeson
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
12. IPD Sharing Statement
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Regional Lung Imaging Using Hyperpolarized Xenon Gas
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