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Trial Outcomes & Findings for Functional Applications of Hyperpolarized 129Xe MRI (NCT NCT01697332)

NCT ID: NCT01697332

Last Updated: 2018-04-17

Results Overview

Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

4 years

Results posted on

2018-04-17

Participant Flow

Participant milestones

Participant milestones
Measure
Subjects With and Without COPD
All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function. Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.
Overall Study
STARTED
1
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Functional Applications of Hyperpolarized 129Xe MRI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Subjects With and Without COPD
n=1 Participants
All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function. Hyperpolarized 129Xe gas: 800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Sex: Female, Male
Female
0 Participants
n=93 Participants
Sex: Female, Male
Male
1 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=93 Participants
Race (NIH/OMB)
White
1 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Region of Enrollment
United States
1 participants
n=93 Participants

PRIMARY outcome

Timeframe: 4 years

Population: No data collected or analyzed for this outcome measure.

Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 years

Population: No data analyzed or collected for this outcome measure.

Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 4 years

Population: No data analyzed or collected for this outcome measure.

Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.

Outcome measures

Outcome data not reported

Adverse Events

Subjects With and Without COPD

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samuel Patz

Brigham and Women's Hospital

Phone: 6172780616

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place