Trial Outcomes & Findings for The Prone to Supine Breast MRI Trial (NCT NCT03573804)

NCT ID: NCT03573804

Last Updated: 2021-08-30

Results Overview

Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2021-08-30

Participant Flow

Participant milestones

Measure	Prone to Supine MRI The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material. Prone to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.
Overall Study STARTED	72
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Measure

Prone to Supine MRI The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material. Prone to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.

Overall Study claustrophobia or MRI table problems

10

Baseline Characteristics

The Prone to Supine Breast MRI Trial

Baseline characteristics by cohort

Measure	Prone to Supine MRI n=72 Participants The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material. Prone to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.

Outcome measures

Measure	Prone to Supine MRI Evaluated by Radiologist A n=62 Participants Radiologist A, number of participants successfully segmented	Prone to Supine MRI Evaluated by Radiologist B n=62 Participants Radiologist B, number of participants successfully segmented
Number of Successful Segmentation of Supine MRI Images	54 Participants	61 Participants

SECONDARY outcome

Timeframe: 30 minutes

Population: One participant was not able to complete both the Prone and Supine Imaging and was excluded.

Compare the signal intensity with that obtained at tumor location on the prone and supine imaging. The amount of enhancement at the tumor site = segmented tumor.

Outcome measures

Measure	Prone to Supine MRI Evaluated by Radiologist A n=61 Participants Radiologist A, number of participants successfully segmented	Prone to Supine MRI Evaluated by Radiologist B n=61 Participants Radiologist B, number of participants successfully segmented
Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor	370.09 Tesla per second Interval 63.33 to 958.31	594.77 Tesla per second Interval 81.5 to 1520.94

SECONDARY outcome

Timeframe: 30 minutes

Population: One participant was not able to complete both the Prone and Supine Imaging and was excluded.

Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.

Outcome measures

Measure	Prone to Supine MRI Evaluated by Radiologist A n=61 Participants Radiologist A, number of participants successfully segmented	Prone to Supine MRI Evaluated by Radiologist B n=61 Participants Radiologist B, number of participants successfully segmented
Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary	217.96 Tesla per second Interval 42.3 to 534.75	383.80 Tesla per second Interval 35.53 to 1108.08

SECONDARY outcome

Timeframe: 30 minutes

Population: One participant was not able to complete both the Prone and Supine Imaging and was excluded.

Mean MRI signal of the segmented tumor divided by the mean MRI signal of the surrounding tissue which has an equal volume to the tumor. The difference between tumor and benign breast tissue is the tumor-to-background ratio

Outcome measures

Measure	Prone to Supine MRI Evaluated by Radiologist A n=61 Participants Radiologist A, number of participants successfully segmented	Prone to Supine MRI Evaluated by Radiologist B n=61 Participants Radiologist B, number of participants successfully segmented
Enhancement Quantification- Tumor-to-Background Ratio	1.74 Ratio Interval 1.07 to 3.56	1.62 Ratio Interval 0.88 to 3.86

SECONDARY outcome

Timeframe: 30 Minutes

Calculate the additional time needed to obtain supine MRI images. After the completion of Prone imaging, the patient was removed from the MRI, turned over to the supine position, new coils placed, and returned to the MRI for additional imaging. The aggregate time to accomplish these tasks are noted in minutes.

Outcome measures

Measure	Prone to Supine MRI Evaluated by Radiologist A n=62 Participants Radiologist A, number of participants successfully segmented	Prone to Supine MRI Evaluated by Radiologist B Radiologist B, number of participants successfully segmented
Time to Position and Obtain Supine Images	7.25 minutes Interval 5.0 to 15.92	—

SECONDARY outcome

Timeframe: Within 15 minutes of the scan

Population: This assessment of overall perceived comfort was added to the study during the study period, and only the last 28 patients evaluated their overall comfort with the prone and supine portions of the examination.

Quantify the perceived comfort level of the prone and supine MRI as reported by participants. A single question using a Likert scale was was used. The scale range was 0 to 5, where 0 = no pain, completely comfortable and 5 = considerable discomfort.

Outcome measures

Measure	Prone to Supine MRI Evaluated by Radiologist A n=28 Participants Radiologist A, number of participants successfully segmented	Prone to Supine MRI Evaluated by Radiologist B n=28 Participants Radiologist B, number of participants successfully segmented
Overall Comfort for Prone and Supine Positions	1.82 units on a scale Interval 0.0 to 5.0	0.61 units on a scale Interval 0.0 to 5.0

Adverse Events

Prone to Supine MRI

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

Timothy B Rooney, MD, PI

Dartmouth-Hitchcock

Phone: 603-650-5000

Email: timothy.b.rooney@hitchcock.org

Results disclosure agreements

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