Trial Outcomes & Findings for A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery (NCT NCT01929395)

NCT ID: NCT01929395

Last Updated: 2019-04-30

Results Overview

Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 159 participants
• Primary outcome timeframe: From baseline MRI to intraoperative measurements: 30 days
• Results posted on: 2019-04-30

Participant Flow

No participants from Phase 1 participated in Phase 2

Participant milestones

Measure	Phase 1: Addition of Supine MRI to Conventional Imaging Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Addition of Supine MRI to Conventional Imaging Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Conventional Imaging (SOC) Wire localized (group WL) partial mastectomy
Overall Study STARTED	19	70	70
Overall Study COMPLETED	18	69	69
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Measure	Phase 1: Addition of Supine MRI to Conventional Imaging Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Addition of Supine MRI to Conventional Imaging Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Conventional Imaging (SOC) Wire localized (group WL) partial mastectomy
Overall Study Did not complete - non-related toxicity	1	0	0
Overall Study Withdrawal by Subject	0	1	0
Overall Study Screen Fail	0	0	1

Baseline Characteristics

A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery

Baseline characteristics by cohort

Measure	Phase 1: Addition of Supine MRI to Conventional Imaging n=18 Participants Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Addition of Supine MRI to Conventional Imaging n=69 Participants Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Conventional Imaging (SOC) n=69 Participants Wire localized (group WL) partial mastectomy	Total n=156 Participants Total of all reporting groups
Age, Customized >=18 years	18 Participants n=5 Participants	69 Participants n=7 Participants	69 Participants n=5 Participants	156 Participants n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	69 Participants n=7 Participants	69 Participants n=5 Participants	156 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	69 Participants n=7 Participants	69 Participants n=5 Participants	156 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	18 participants n=5 Participants	69 participants n=7 Participants	69 participants n=5 Participants	156 participants n=4 Participants

PRIMARY outcome

Timeframe: From baseline MRI to intraoperative measurements: 30 days

Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.

Outcome measures

Measure	Phase 1: Addition of Supine MRI to Conventional Imaging n=18 Participants Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Conventional Imaging (SOC) Wire localized (group WL) partial mastectomy
The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.	7.2 mm Interval 0.0 to 19.0	—

PRIMARY outcome

Timeframe: 30 days from surgery

The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria.

Outcome measures

Measure	Phase 1: Addition of Supine MRI to Conventional Imaging n=68 Participants Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Conventional Imaging (SOC) n=69 Participants Wire localized (group WL) partial mastectomy
To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery.	8 Participants	16 Participants

SECONDARY outcome

Timeframe: 30 days from surgery

The mean specimen volumes to be compared using t - statistics. The concordance between lesion volumes identified on the supine MRI images and the prone MRI images will be evaluated through correlation and regression analysis.

Outcome measures

Measure	Phase 1: Addition of Supine MRI to Conventional Imaging n=68 Participants Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Conventional Imaging (SOC) n=69 Participants Wire localized (group WL) partial mastectomy
Differences Between the Two Groups in the Volume of Breast Tissue Removed	74 ml Standard Deviation 33.9	69.8 ml Standard Deviation 25.1

Adverse Events

Phase 1: Addition of Supine MRI to Conventional Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 2: Addition of Supine MRI to Conventional Imaging

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 2: Conventional Imaging (SOC)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phase 1: Addition of Supine MRI to Conventional Imaging n=18 participants at risk Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Addition of Supine MRI to Conventional Imaging n=69 participants at risk Pre-operative supine MRI with intraoperative optical scanning and tracking (group MRI)	Phase 2: Conventional Imaging (SOC) n=69 participants at risk Wire localized (group WL) partial mastectomy
Reproductive system and breast disorders Hematoma	0.00% 0/18 • From the inception of Phase 1 (baseline) to end of intervention for Phase 2: 7 years Regular investigator assessment and regular laboratory testing	1.4% 1/69 • Number of events 1 • From the inception of Phase 1 (baseline) to end of intervention for Phase 2: 7 years Regular investigator assessment and regular laboratory testing	1.4% 1/69 • Number of events 1 • From the inception of Phase 1 (baseline) to end of intervention for Phase 2: 7 years Regular investigator assessment and regular laboratory testing

Other adverse events

Adverse event data not reported

Additional Information

Dr Richard J. Barth Jr.

Dartmouth Hitchcock Medical Center

Phone: (603) 650-9479

Email: Richard.J.Barth.Jr@hitchcock.org

Results disclosure agreements

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