Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | 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) |
| |
| Chronic Obstructive Pulmonary Disease | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperpolarised 129 Xenon | Other | Hyperpolarised 129 Xe to assess lung function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acquisition of baseline data and images to investigate use of hp129Xe as a diagnostic tool | 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 | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Collation of data regarding ability of participants to adhere to the study protocol | 1) To collate data regarding the ability of participants of each group to adhere to the protocol thus informing the study design of future trials. | 4 years |
Not provided
General Inclusion criteria
Inclusion criteria
HEALTHY VOLUNTEERS
• No significant respiratory disease within the last year
PATIENTS
COPD
Exclusion criteria
HEALTHY VOLUNTEERS
PATIENTS
Not provided
Not provided
Not provided
Healthy Volunteers, COPD
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyperpolarised Imaging Lung Facility, QMC, Uni of Nottingham | Nottingham | NG7 2UH | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |