Trial Outcomes & Findings for Repeatability in Hyperpolarized 3-Helium With MRI (NCT NCT03776747)
NCT ID: NCT03776747
Last Updated: 2023-11-01
Results Overview
Validate the intrinsic variability of ADC (cm2/s) as a function of normal procedural and physiological changes in an attempt to standardize the use of the biomarker in future assessments of pulmonary pathologies.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
Through study completion, measurements completed at one day visit only.
Results posted on
2023-11-01
Participant Flow
Participant milestones
| Measure |
Group One: Prone MRI Scans
Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
Prone hyperpolarized 3 helium gas scan: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
Vitals
Pulmonary Function Tests: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
Initial protocol MRI scan: Initial scan to determine placement
|
Group Two: Supine MRI Scans
Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Supine hyperpolarized 3 helium gas scan: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.
Vitals
Pulmonary Function Tests: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
Initial protocol MRI scan: Initial scan to determine placement
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
18
|
|
Overall Study
COMPLETED
|
0
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group One: Prone MRI Scans
Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
Prone hyperpolarized 3 helium gas scan: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
Vitals
Pulmonary Function Tests: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
Initial protocol MRI scan: Initial scan to determine placement
|
Group Two: Supine MRI Scans
n=18 Participants
Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Supine hyperpolarized 3 helium gas scan: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.
Vitals
Pulmonary Function Tests: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
Initial protocol MRI scan: Initial scan to determine placement
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
|
17 Participants
n=18 Participants
|
17 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
—
|
8 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
—
|
10 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
—
|
18 participants
n=18 Participants
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Through study completion, measurements completed at one day visit only.Population: Only Supine MRI's were performed. ADC values at 20%, 60% and 100% vital capacity (VC) were compared against each other.
Validate the intrinsic variability of ADC (cm2/s) as a function of normal procedural and physiological changes in an attempt to standardize the use of the biomarker in future assessments of pulmonary pathologies.
Outcome measures
| Measure |
Group One: Prone MRI Scans
Subjects will have vitals, pulmonary function tests, initial proton MRI scan, prone hyperpolarized 3 helium gas scan
Prone hyperpolarized 3 helium gas scan: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
Vitals
Pulmonary Function Tests: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
Initial protocol MRI scan: Initial scan to determine placement
|
Group Two: Supine MRI Scans
n=18 Participants
Subjects will have vitals, pulmonary function tests, initial protocol MRI scan, supine hyperpolarized 3 helium gas scan
Supine hyperpolarized 3 helium gas scan: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.
Vitals
Pulmonary Function Tests: Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
Initial protocol MRI scan: Initial scan to determine placement
|
|---|---|---|
|
Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.
20% VC
|
—
|
0.167 ADC (cm2/sec)
Standard Deviation .018
|
|
Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.
60% VC
|
—
|
0.175 ADC (cm2/sec)
Standard Deviation .015
|
|
Apparent Diffusion Coefficient (ADC) as a Function of Lung Inflation Levels.
100% VC
|
—
|
0.188 ADC (cm2/sec)
Standard Deviation .020
|
Adverse Events
Group One: Prone MRI Scans
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Two: Supine MRI Scans
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place