Trial Outcomes & Findings for Hyperpolarized Xenon Gas MR Imaging in NSCLC Radiotherapy (NCT NCT02151604)
NCT ID: NCT02151604
Last Updated: 2023-02-23
Results Overview
Number of participants with a change from baseline in ventilation map using hyperpolarized Xe-129
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Mid-point of radiotherapy - varies depending on the duration of treatment prescribed, between 1 week to 2 months from the baseline scan (range: 7 days to 60 days). For example, for 2 weeks of radiotherapy, this would be at 1 week post-baseline.
Results posted on
2023-02-23
Participant Flow
Recruited from the lung cancer oncology clinics by the oncology team Recruitment period: 23/04/2014 to 30/11/2019
All participants were recruited to one arm. No control or comparative cohort in this study
Participant milestones
| Measure |
129 Xenon MR Imaging Group
Xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Inhalation of hyperpolarized xenon gas: The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Patients with cancer with planned radiotherapy to their thorax which may affect their lungs.
Up to 6 xenon scans per visit at baseline (pre-treatment), mid-point, end of radiotherapy and 4 weeks after. Patientswith lung cancer would already receive CT chest at the baseline, end-of-treatment visits and 4 weeks after that.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
129 Xenon MR Imaging Group
Xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Inhalation of hyperpolarized xenon gas: The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Patients with cancer with planned radiotherapy to their thorax which may affect their lungs.
Up to 6 xenon scans per visit at baseline (pre-treatment), mid-point, end of radiotherapy and 4 weeks after. Patientswith lung cancer would already receive CT chest at the baseline, end-of-treatment visits and 4 weeks after that.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Hyperpolarized Xenon Gas MR Imaging in NSCLC Radiotherapy
Baseline characteristics by cohort
| Measure |
129 Xenon MR Imaging
n=22 Participants
Xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Inhalation of hyperpolarized xenon gas: The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
|
|---|---|
|
Age, Continuous
|
72.10 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
22 Participants
n=5 Participants
|
|
Pulmonary Function Tests
|
11 Participants
n=5 Participants
|
|
Ventilation/perfusion nuclear medicine scan (optional)
|
0 Participants
n=5 Participants
|
|
Computed Tomography (CT) of the Chest
|
14 Participants
n=5 Participants
|
|
Hyperpolarized Xe-129 MR Imaging
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Mid-point of radiotherapy - varies depending on the duration of treatment prescribed, between 1 week to 2 months from the baseline scan (range: 7 days to 60 days). For example, for 2 weeks of radiotherapy, this would be at 1 week post-baseline.Population: 10 patients had at least one follow-up after baseline
Number of participants with a change from baseline in ventilation map using hyperpolarized Xe-129
Outcome measures
| Measure |
129 Xenon MR Imaging Group
n=10 Participants
Xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Inhalation of hyperpolarized xenon gas: The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Patients with cancer with planned radiotherapy to their thorax which may affect their lungs.
Up to 6 xenon scans per visit at baseline (pre-treatment), mid-point, end fo radiotherapy and 4 weeks later.
Lungg cancer patients would already receive CT chest at the baseline and end-of-treatment visits and 4 weeks follow-up.
|
|---|---|
|
Number of Participants With a Change From Baseline in Ventilation Map Using Hyperpolarized Xe-129 MR Imaging
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 months after completion of treatmentPopulation: Ventilation MRI acquired for 5 patients 3 months after treatment completion
Number of participants with a change in ventilation MRI acquired for 5 patients, 3 months after treatment completion ADC not acquired in this study
Outcome measures
| Measure |
129 Xenon MR Imaging Group
n=5 Participants
Xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Inhalation of hyperpolarized xenon gas: The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Patients with cancer with planned radiotherapy to their thorax which may affect their lungs.
Up to 6 xenon scans per visit at baseline (pre-treatment), mid-point, end fo radiotherapy and 4 weeks later.
Lungg cancer patients would already receive CT chest at the baseline and end-of-treatment visits and 4 weeks follow-up.
|
|---|---|
|
Number of Participants With a Change in Ventilation and ADC Maps Using Hyperpolarized Xe-129 MR Imaging From Baseline to 3 Months Post Radiotherapy Completion
|
3 Participants
|
SECONDARY outcome
Timeframe: Mid-point of radiotherapy - varies depending on the duration of treatment prescribed, between 1 week to 2 months from the baseline scan - Range: 7-60 days.) For example, for 2 weeks of radiotherapy, this would be at 1 week post-baseline.Population: Participants with mid-point follow-up
Correlation between change in ventilation or ADC maps using hyperpolarized Xe-129 MR imaging and change in lung function from baseline to follow-up (during treatment), acquired at the mid-point of treatment.
Outcome measures
| Measure |
129 Xenon MR Imaging Group
n=10 Participants
Xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Inhalation of hyperpolarized xenon gas: The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Patients with cancer with planned radiotherapy to their thorax which may affect their lungs.
Up to 6 xenon scans per visit at baseline (pre-treatment), mid-point, end fo radiotherapy and 4 weeks later.
Lungg cancer patients would already receive CT chest at the baseline and end-of-treatment visits and 4 weeks follow-up.
|
|---|---|
|
Correlation Between Change in Ventilation/ ADC Maps Using Hyperpolarized Xe-129 MR Imaging and Change in Lung Function From Baseline to Follow-up (During Treatment)
Alveolar volume (VA)
|
0.60 Pearson's Coorelation Coefficient
|
|
Correlation Between Change in Ventilation/ ADC Maps Using Hyperpolarized Xe-129 MR Imaging and Change in Lung Function From Baseline to Follow-up (During Treatment)
Diffusing capacity for carbon monoxide(TLCO)
|
0.70 Pearson's Coorelation Coefficient
|
|
Correlation Between Change in Ventilation/ ADC Maps Using Hyperpolarized Xe-129 MR Imaging and Change in Lung Function From Baseline to Follow-up (During Treatment)
Residual volume (RV)
|
-0.85 Pearson's Coorelation Coefficient
|
|
Correlation Between Change in Ventilation/ ADC Maps Using Hyperpolarized Xe-129 MR Imaging and Change in Lung Function From Baseline to Follow-up (During Treatment)
Functional residual capacity (FRC)
|
-0.95 Pearson's Coorelation Coefficient
|
|
Correlation Between Change in Ventilation/ ADC Maps Using Hyperpolarized Xe-129 MR Imaging and Change in Lung Function From Baseline to Follow-up (During Treatment)
Inspiratory capacity(IC)
|
-0.88 Pearson's Coorelation Coefficient
|
Adverse Events
129 Xenon MR Imaging Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
129 Xenon MR Imaging Group
n=22 participants at risk
Xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Inhalation of hyperpolarized xenon gas: The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
Patients with cancer with planned radiotherapy to their thorax which may affect their lungs.
Up to 6 xenon scans per visit at baseline (pre-treatment), mid-point, and end fo radiotherapy. Patients would already receive CT chest at the baseline and end-of-treatment visits.
|
|---|---|
|
Nervous system disorders
Dizziness
|
36.4%
8/22 • Number of events 19 • Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
|
|
Nervous system disorders
Dysgeusia
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
31.8%
7/22 • Number of events 10 • Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
|
|
Nervous system disorders
Euphoria
|
9.1%
2/22 • Number of events 3 • Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
|
|
Cardiac disorders
Palpitations
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
|
|
Gastrointestinal disorders
Hypersalivation
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
|
|
Reproductive system and breast disorders
Chest tightness
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
|
|
Nervous system disorders
Paresthesia (Lips)
|
4.5%
1/22 • Number of events 1 • Adverse events were collected from the participants from the time of the first bag of xenon inhaled until 2 weeks after the date of the last scan, up to 6 months
Standard definitions apply. All AEs observed by the investigator or reported by the patient during and for 24 hours following xenon MRI are reported. Only adverse events where there is a reasonable possibility of a relationship to xenon, and any adverse event considered to be of medical interest/ importance are reported. Description, date of onset and end date, severity, assessment of relatedness to trial medication, other suspect drug or device and action taken will be recorded.
|
Additional Information
Avianna Laws, Clinical Research Operations Manager
Oxford University Hospitals NHS Foundation Trust
Phone: 01865 (2)26221
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place