- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02912637
Hyperpolarized Xenon Imaging in Patients With Cystic Fibrosis
Hyperpolarised 129Xe MRI for Non-invasive Assessment of Ventilation, Perfusion and the Alveolar Membrane - a Physiological Study in Healthy Volunteers & Cystic Fibrosis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hyperpolarised gas MRI (3He and 129Xe) has enabled novel methods of in-vivo functional lung imaging that do not rely on the use of ionising radiation. Hyperpolarised 129Xe (HP Xe) MRI provides additional complementary information to 3He and 1H MRI and conventional lung imaging modalities. By virtue of its solubility, the 129Xe contrast agent follows the gas exchange pathways in the lungs, offering a direct means to explore regional ventilation-perfusion (V/Q). The competing modality of nuclear medicine lung V/Q scans suffer from very poor spatial resolution and a reliance on high doses of radiation via radio-nuclide inhalation. Nuclear medicine is thus unsuitable for studies of basic physiology in healthy volunteers or in longitudinal studies in lung disease patients.
The aims and objectives of this study are:
- To assess the physiological differences in lung ventilation between the normal group (volunteers) and the cystic fibrosis disease group
- To evaluate differences in Xe diffusion across the alveolar membrane between the normal group (volunteers) and the cystic fibrosis disease group
- To understand the relationship between the extent of abnormal ventilation (and ventilation-perfusion mismatch) on MRI and the results from conventional physiological evaluation of lung function using pulmonary function tests (spirometry and gas exchange)
- To understand the relationship between gas exchange as determined by HP Xe imaging with the extent of ventilation perfusion mismatch on standard perfusion MRI
This is a physiological cross-sectional feasibility study comparing regional lung ventilation and diffusion across the alveolar membrane in normal volunteers and cystic fibrosis. 15 healthy volunteers and 15 cystic fibrosis patients will be recruited. All imaging will take place at Papworth Hospital.
Phase I: Volunteer study (n=15, aged 18-70)
Hyperpolarised 129Xe MRI scans will be performed in the MRI department at Papworth Hospital, using a Siemens Avanto 1.5 Tesla system with 129Xe capability using a dedicated transmit-receive RF coil.
Phase II: CF study (n=15, aged 18-70)
Patients already enrolled in the study 'Pulmonary magnetic resonance imaging in cystic fibrosis: accuracy and reproducibility' (REC reference: 13/EE/0401; IRAS project ID: 73137) will be invited to take part in this study too.
These patients, with CF in stable phase, will be evaluated with same day conventional MRI, lung function tests and clinical scoring. The methodology of 129Xe MRI will be as described above for healthy volunteers.
Morphological imaging: A combination of T1 and T2 weighted sequences will be used.
Hyperpolarized 129Xe MR imaging: For each subject, up to two deliveries of ≤ 1L doses of hyperpolarised xenon will take place as follows:-
- 129Xe ventilation imaging will provide further information on assessment of lung ventilation volume using a volumetric gradient echo sequence.
- Chemical shift saturation recovery (CSSR) spectroscopy with dissolved xenon will provide an estimation of the fraction of 129Xe in tissue/interstitium and in red blood cells.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
- Papworth Hospital NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years or above with proven CF, and:
- Clinical stable disease over last month, defined as:
One month without intravenous antibiotics for airways disease, and:
One month without evidence for decrease in lung function (no evidenced drop in FEV1 or PEFR >10%).
Exclusion criteria:
- Contraindications to MR (presence of non MR compatible pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or metallic foreign objects in the eyes, pregnancy, and severe claustrophobia),
- Ability to breath hold below 15 seconds.
- Current (> 6 months) smoker
Volunteer inclusion criteria:
- No history of acute (within the last 6 months) or chronic illness (this will be determined by direct communication with the volunteer and not from their medical records)
Volunteer exclusion Criteria:
- As patients
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CF patients
Hyperpolarized Xenon MRI
|
MRI & MRS of lung using inhaled hyperpolarized Xenon as a contrast agent
|
Healthy volunteers
Hyperpolarized Xenon MRI
|
MRI & MRS of lung using inhaled hyperpolarized Xenon as a contrast agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung ventilation assessed by Percentage Ventilation Defect (VD%)
Time Frame: 24 hours
|
Quantitative measure of lung ventilation
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced expiratory volume (%) in 1 second (FEV1)
Time Frame: 24 hours
|
Quantitative measure of lung function
|
24 hours
|
Percentage perfusion defect (PD%)
Time Frame: 24 hours
|
Quantitative measure of lung perfusion
|
24 hours
|
Regional ventilation: perfusion (1-VD%)/(1-PD%) ratio
Time Frame: 24 hours
|
Quantitative measure of regional lung function
|
24 hours
|
CF Brody score assessed on CT in patient group
Time Frame: 24 hours
|
Disease severity (in patients) assessed by routine CT
|
24 hours
|
Percentage ventilation defect assessed on CT (hypoattenuation) - patient group only
Time Frame: 24 hours
|
Disease severity (in patients) assessed by quantitative measure of ventilation on routine CT
|
24 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicholas J Screaton, Papworth NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Respiratory Tract Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Pancreatic Diseases
- Fibrosis
- Cystic Fibrosis
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Anesthetics, Inhalation
- Xenon
Other Study ID Numbers
- P02215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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