Trial Outcomes & Findings for MRI Only Radiation Therapy With CPAP (NCT NCT03397342)
NCT ID: NCT03397342
Last Updated: 2024-01-18
Results Overview
The primary endpoint of aim 1 is that for the subjects enrolled in the study there is no statistically significant difference in ITV (internal target volumes) between subjects whose treatment is planned with MRI compared to subjects whose treatment is planned with 4D-CT.
TERMINATED
NA
5 participants
baseline
2024-01-18
Participant Flow
Five healthy volunteers were enrolled into the study prior to termination
Participant milestones
| Measure |
Standard Breath Hold (4D-MRI Without CPAP)
1. Breath-hold CT and 4D-CT without CPAP
2. Breath-hold MRI and 4D-MRI without CPAP a) T1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images
|
CPAP Intervention (4D-MRI With CPAP)
1. Breath-hold CT without CPAP
2. 4D-CT with and without CPAP
3. 4D-MRI with CPAP
1. T1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images
CPAP machine: Use of CPAP machine during MRI
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MRI Only Radiation Therapy With CPAP
Baseline characteristics by cohort
| Measure |
Standard Breath Hold (4D-MRI Without CPAP)
n=5 Participants
1. Breath-hold CT and 4D-CT without CPAP
2. Breath-hold MRI and 4D-MRI without CPAP a) T1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images
|
CPAP Intervention (4D-MRI With CPAP)
1. Breath-hold CT without CPAP
2. 4D-CT with and without CPAP
3. 4D-MRI with CPAP
1. T1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images
CPAP machine: Use of CPAP machine during MRI
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-29 years old
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Customized
20-29 years old
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
30-39 years old
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
40-49 years old
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
50+ years old
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
—
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
—
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
—
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
—
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: Internal target volume (ITV) assessments were not conducted as only healthy volunteers were enrolled into the study. There is no data to report.
The primary endpoint of aim 1 is that for the subjects enrolled in the study there is no statistically significant difference in ITV (internal target volumes) between subjects whose treatment is planned with MRI compared to subjects whose treatment is planned with 4D-CT.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baselinePopulation: No participants were enrolled into the arm/group entailing 4D-MRI with CPAP and, as such, there is no tumor motion data to evaluate.
The primary end point of aim 2 is that for the subjects enrolled in Continuous Positive Airway Pressure (CPAP) arm an average tumor motion reduction of at least 12% can be achieved when CPAP is used compared to free breathing.
Outcome measures
Outcome data not reported
Adverse Events
Standard Breath Hold (4D-MRI Without CPAP)
CPAP Intervention (4D-MRI With CPAP)
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