Trial Outcomes & Findings for Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment (NCT NCT02478255)
NCT ID: NCT02478255
Last Updated: 2023-02-17
Results Overview
"Ventilation" is defined as the regional 129Xe airspace signal divided by the top 1% of 129Xe airspace signal (representing open-airway ventilation). A "Ventilation Defect" is defined as any region of lung where the Ventilation signal is more than 2 standard deviations below the mean Ventilation signal of healthy volunteer subjects' lungs. "Ventilation Defect Percentage", or VDP, is defined as the volume of a subject's Ventilation Defects divided by the volume of the subject's lung, multiplied by 100%.
COMPLETED
PHASE2
25 participants
Baseline, following radiation treatment (up to 3 months)
2023-02-17
Participant Flow
Participant milestones
| Measure |
Patients Scheduled to Undergo Radiation Therapy (RT)
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
Healthy Volunteers
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
| Measure |
Patients Scheduled to Undergo Radiation Therapy (RT)
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
Healthy Volunteers
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
|---|---|---|
|
Overall Study
Physician Decision
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Baseline characteristics by cohort
| Measure |
Patients Scheduled to Undergo Radiation Therapy (RT)
n=17 Participants
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
Healthy Volunteers
n=8 Participants
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.4 years
n=5 Participants
|
34 years
n=7 Participants
|
54.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, following radiation treatment (up to 3 months)Population: Subjects that completed visit 1 and visit 2 (n=10) were analyzed. Not applicable to the healthy volunteers group.
"Ventilation" is defined as the regional 129Xe airspace signal divided by the top 1% of 129Xe airspace signal (representing open-airway ventilation). A "Ventilation Defect" is defined as any region of lung where the Ventilation signal is more than 2 standard deviations below the mean Ventilation signal of healthy volunteer subjects' lungs. "Ventilation Defect Percentage", or VDP, is defined as the volume of a subject's Ventilation Defects divided by the volume of the subject's lung, multiplied by 100%.
Outcome measures
| Measure |
Patients Scheduled to Undergo Radiation Therapy (RT)
n=10 Participants
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
Healthy Volunteers
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
|---|---|---|
|
Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP)
|
-2.20 Ventilation Defect Percentage (VDP)
Standard Error 1.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, following RT (up to 3 months)Population: Subjects that competed visit 1 and visit 2 (n=10) were analyzed. Not applicable to the healthy volunteers group.
"Gas exchange" is defined as the ratio of the signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the local 129Xe airspace signal. In other publications, the investigators have referred to this as "RBC (red blood cell) transfer". A "Gas Exchange Defect" is defined as any region of lung where the Gas Exchange signal is more than 2 standard deviations below the mean Gas Exchange signal of healthy volunteer subjects' lungs. "Gas Exchange Defect Percentage", or EDP, is defined as the volume of a subject's Gas Exchange Defects divided by the volume of the subject's lung, multiplied by 100%.
Outcome measures
| Measure |
Patients Scheduled to Undergo Radiation Therapy (RT)
n=10 Participants
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
Healthy Volunteers
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
|---|---|---|
|
Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment)
|
5.20 Gas Exchange Defect Percentage (EDP)
Standard Error 2.6
|
—
|
SECONDARY outcome
Timeframe: Baseline, following RT (up to 3 months)Population: Subjects that competed visit 1 and visit 2 (n=10) were analyzed. Not applicable to the healthy volunteers group.
"RBC:barrier ratio" is defined as the ratio of the whole lung signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the whole lung signal from 129Xe in the alveolar barrier tissue.
Outcome measures
| Measure |
Patients Scheduled to Undergo Radiation Therapy (RT)
n=10 Participants
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
Healthy Volunteers
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
|---|---|---|
|
RBC (Red Blood Cell) to Barrier Ratio Following RT
|
-0.021 Ratio
Standard Error 0.016
|
—
|
SECONDARY outcome
Timeframe: Baseline, following RT (up to 3 months)Population: Subjects that competed visit 1 and visit 2 (n=10) were analyzed. Not applicable to the healthy volunteers group.
"Barrier Uptake" is defined as the ratio of the regional signal from 129Xe dissolved in the interstitial space within the alveolar walls to the regional signal from 129Xe in the adjacent airspaces. "High Barrier Uptake" is defined as any region of lung where the Barrier Uptake signal is more than 2 standard deviations above the mean Barrier Uptake signal of healthy volunteer subjects' lungs. "High Barrier Uptake Percentage", or HBUP, is defined as the volume of a subject's lung exhibiting High Barrier Uptake divided by the total volume of the subject's lung, multiplied by 100%.
Outcome measures
| Measure |
Patients Scheduled to Undergo Radiation Therapy (RT)
n=10 Participants
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
Healthy Volunteers
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
|
|---|---|---|
|
Change in High Barrier Uptake Percentage (HBUP) Following RT
|
5.0 Interstitial space to alveolar walls (%)
Standard Error 4.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, following RT (up to 3 months)Outcome measures
Outcome data not reported
Adverse Events
Patients Scheduled to Undergo Radiation Therapy (RT)
Healthy Volunteers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bastiaan Driehuys, PhD (Professor of Radiology)
Duke University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place