Trial Outcomes & Findings for Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection (NCT NCT03417687)

Last Updated: 2022-06-28

Results Overview

Predicted percentage of remaining pulmonary function is a pre-specified section of lung were to be removed. Investigators indicated which portions of lung were likely to be resected. Remaining percentage of pulmonary function was determined by subtracting the percentage of pulmonary function contributed by the planned zone of resection from the total pulmonary function using a standard 6-zone image analysis of the lung. The difference between predicted percentage of remaining pulmonary function was calculated by subtracting the value derived from the 133Xe scintigraphy image from the value derived from the 129Xe MRI image (e.g. 129Xe - 133Xe).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

38 participants

Primary outcome timeframe

48 hours

Results posted on

2022-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	129Xe Before 133Xe Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy 129Xe MRI: Evaluation of pulmonary function 133 Xe scintigraphy: Evaluation of pulmonary function	133Xe Before 129Xe Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI 129Xe MRI: Evaluation of pulmonary function 133 Xe scintigraphy: Evaluation of pulmonary function
Overall Study STARTED	18	20
Overall Study Received 129Xe	14	20
Overall Study Received 133Xe	13	20
Overall Study COMPLETED	14	20
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	129Xe Before 133Xe n=14 Participants Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy 129Xe MRI: Evaluation of pulmonary function 133 Xe scintigraphy: Evaluation of pulmonary function	133Xe Before 129Xe n=20 Participants Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI 129Xe MRI: Evaluation of pulmonary function 133 Xe scintigraphy: Evaluation of pulmonary function	Total n=34 Participants Total of all reporting groups
Age, Continuous	58.5 years STANDARD_DEVIATION 11.5 • n=5 Participants	64.9 years STANDARD_DEVIATION 7.6 • n=7 Participants	62.2 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	20 Participants n=7 Participants	34 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	1 Participants n=7 Participants	1 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	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	14 participants n=5 Participants	20 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: The Efficacy Analysis Set is the group of subjects who had both a 129Xe MRI scan and a 133Xe scintigraphy scan, and for whom both scans met quality control criteria for analysis (as defined in the Independent Review Charter).

Outcome measures

Outcome measures
Measure	129Xe MRI n=32 Participants All subjects receiving a 129Xe MRI of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.	133Xe n=32 Participants All subjects receiving a 133Xe scintigraphy scan of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
Predicted Percentage of Remaining Pulmonary Function	73.4 percentage of remaining function Standard Deviation 13.0	71.9 percentage of remaining function Standard Deviation 12.1

SECONDARY outcome

Timeframe: 3 months

Population: This analysis set of all subjects that met the criteria for inclusion in the efficacy analysis set and had a post-operative FEV1 (spirometry) value.

The difference between the scan-predicted post-operative FEV1 and the measured post-operative FEV1

Outcome measures

Outcome measures
Measure	129Xe MRI n=32 Participants All subjects receiving a 129Xe MRI of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.	133Xe n=32 Participants All subjects receiving a 133Xe scintigraphy scan of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
Predicted Versus Measured FEV1	-0.65 liters Standard Deviation 0.60	-0.65 liters Standard Deviation 0.66

SECONDARY outcome

Timeframe: 48 hours

The fraction of total ventilation contributed by the lower left lung zone on 6-zone analysis.

Outcome measures

Outcome measures
Measure	129Xe MRI n=32 Participants All subjects receiving a 129Xe MRI of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.	133Xe n=32 Participants All subjects receiving a 133Xe scintigraphy scan of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
Measured Percentage of Total Ventilation Contributed by the Lower Left Lung Zone.	16.08 percentage of total function Standard Deviation 4.43	12.37 percentage of total function Standard Deviation 3.60

SECONDARY outcome

Timeframe: 48 hours

The fraction of total ventilation contributed by the upper left lung zone on 6-zone analysis.

Outcome measures

Outcome measures
Measure	129Xe MRI n=32 Participants All subjects receiving a 129Xe MRI of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.	133Xe n=32 Participants All subjects receiving a 133Xe scintigraphy scan of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
Measured Percentage of Total Ventilation Contributed by the Upper Left Lung Zone.	10.67 percentage of total function Standard Deviation 2.11	10.28 percentage of total function Standard Deviation 2.72

SECONDARY outcome

Timeframe: 48 hours

The fraction of total ventilation contributed by the middle left lung zone on 6-zone analysis.

Outcome measures

Outcome measures
Measure	129Xe MRI n=32 Participants All subjects receiving a 129Xe MRI of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.	133Xe n=32 Participants All subjects receiving a 133Xe scintigraphy scan of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
Measured Percentage of Total Ventilation Contributed by the Middle Left Lung Zone.	22.27 percentage of total function Standard Deviation 3.71	20.92 percentage of total function Standard Deviation 2.88

SECONDARY outcome

Timeframe: 48 hours

The fraction of total ventilation contributed by the upper right lung zone on 6-zone analysis.

Outcome measures

Outcome measures
Measure	129Xe MRI n=32 Participants All subjects receiving a 129Xe MRI of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.	133Xe n=32 Participants All subjects receiving a 133Xe scintigraphy scan of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
Measured Percentage of Total Ventilation Contributed by the Upper Right Lung Zone.	11.16 percentage of total function Standard Deviation 2.97	12.12 percentage of total function Standard Deviation 2.56

SECONDARY outcome

Timeframe: 48 hours

The fraction of total ventilation contributed by the middle right lung zone on 6-zone analysis.

Outcome measures

Outcome measures
Measure	129Xe MRI n=32 Participants All subjects receiving a 129Xe MRI of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.	133Xe n=32 Participants All subjects receiving a 133Xe scintigraphy scan of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
Measured Percentage of Total Ventilation Contributed by the Middle Right Lung Zone.	23.44 percentage of total function Standard Deviation 3.07	26.16 percentage of total function Standard Deviation 3.80

SECONDARY outcome

Timeframe: 48 hours

The fraction of total ventilation contributed by the lower right lung zone on 6-zone analysis.

Outcome measures

Outcome measures
Measure	129Xe MRI n=32 Participants All subjects receiving a 129Xe MRI of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.	133Xe n=32 Participants All subjects receiving a 133Xe scintigraphy scan of their lungs. Subjects received both 129Xe MRI and 133Xe scintigraphy in randomized order.
Measured Percentage of Total Ventilation Contributed by the Lower Right Lung Zone.	16.39 percentage of total function Standard Deviation 4.18	18.16 percentage of total function Standard Deviation 3.62

Adverse Events

129Xe Before 133Xe

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

133Xe Before 129Xe

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	129Xe Before 133Xe n=14 participants at risk Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy 129Xe MRI: Evaluation of pulmonary function 133 Xe scintigraphy: Evaluation of pulmonary function	133Xe Before 129Xe n=20 participants at risk Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI 129Xe MRI: Evaluation of pulmonary function 133 Xe scintigraphy: Evaluation of pulmonary function
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 2 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.

Other adverse events

Additional Information

Laura Sutton

Polarean

Phone: 919-206-7900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Independent analyses and/or publication of trial results by the PI is not permitted without prior written consent of the sponsor. Written permission to investigators to publish results is contingent on review by the sponsor of the methodology and statistical analyses used. The PI must submit all manuscripts to the sponsor at least 60 days prior to submission for review.
Publication restrictions are in place

Restriction type: OTHER

Measure	129Xe Before 133Xe n=14 participants at risk Subjects will undergo hyperpolarized 129Xe MRI first, followed by 133Xe scintigraphy 129Xe MRI: Evaluation of pulmonary function 133 Xe scintigraphy: Evaluation of pulmonary function	133Xe Before 129Xe n=20 participants at risk Subjects will undergo 133Xe scintigraphy first, followed by hyperpolarized 129Xe MRI 129Xe MRI: Evaluation of pulmonary function 133 Xe scintigraphy: Evaluation of pulmonary function
Eye disorders Eye pruritus	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Eye disorders Lacrimation increased	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Gastrointestinal disorders Colitis	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Gastrointestinal disorders Hematemesis	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Gastrointestinal disorders Hypoaesthesia oral	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Gastrointestinal disorders Intestinal pseudo-obstruction	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	5.0% 1/20 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Nervous system disorders Headache	0.00% 0/14 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	10.0% 2/20 • Number of events 2 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Psychiatric disorders Restlessness	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Respiratory, thoracic and mediastinal disorders Pulmonary pain	0.00% 0/14 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	5.0% 1/20 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Skin and subcutaneous tissue disorders Erythema	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Skin and subcutaneous tissue disorders Hair disorder	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Vascular disorders Hot flush	0.00% 0/14 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	5.0% 1/20 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.
Skin and subcutaneous tissue disorders Skin discolouration	7.1% 1/14 • Number of events 1 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.	0.00% 0/20 • 3 days All subjects were dosed with 129Xe and 133Xe on the same day with a mean time between administration of 1.8 hours (range 0.7 hours to 4.9 hours). Therefore reported adverse events could not reliably be attributed to an individual drug. Therefore, adverse events are reported based on the randomized order to which participants received each drug.