Trial Outcomes & Findings for MRI Only Radiation Therapy With CPAP (NCT 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.

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

baseline

Results posted on

2024-01-18

Participant Flow

Five healthy volunteers were enrolled into the study prior to termination

Participant milestones

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

PRIMARY outcome

Timeframe: baseline

Population: Internal target volume (ITV) assessments were not conducted as only healthy volunteers were enrolled into the study. There is no data to report.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: baseline

Population: 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)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CPAP Intervention (4D-MRI With CPAP)

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

Dr. Madhur Garg

Montefiore Medical Center

Phone: 718-920-4140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

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=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized 20-29 years old	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 30-39 years old	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 40-49 years old	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 50+ years old	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	—	5 participants n=5 Participants