Trial Outcomes & Findings for Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy (NCT NCT02956473)

NCT ID: NCT02956473

Last Updated: 2024-03-12

Results Overview

Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)
• Results posted on: 2024-03-12

Participant Flow

Participant milestones

Measure	Supine MRI * Standard MRI will be performed * Supine MRI will be performed * Participant will receive mammography and ultrasound * Breast Radiologist will take a brief survey. * Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care * Standard of care will be performed Supine MRI Neoadjuvant Therapy (NAT) Ultrasound Mammography Standard of Care Standard MRI
Overall Study STARTED	57
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy

Baseline characteristics by cohort

Measure	Supine MRI n=57 Participants * Standard MRI will be performed * Supine MRI will be performed * Participant will receive mammography and ultrasound * Breast Radiologist will take a brief survey. * Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care * Standard of care will be performed Supine MRI Neoadjuvant Therapy (NAT) Ultrasound Mammography Standard of Care Standard MRI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	5 Participants n=5 Participants
Race (NIH/OMB) White	48 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	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)

Population: Analysis performed of 38 patients with Prone MRI imaging measurements and surgical pathology measurements

Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used.

Outcome measures

Measure	Standard (Prone) MRI Tumor Imaging n=38 Participants Comparison of tumor size between standard (prone) MRI imaging and surgical pathology
Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size	0.635 correlation coefficient Interval 0.395 to 0.794

PRIMARY outcome

Timeframe: time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days

Population: We analyzed MRI tumor size and pathologic tumor size for 26 pts with both supine MRI measurements and final pathology measurements

Compared tumor size as reported by radiologist on the clinical report between Supine Breast MRI and The Pathologic Residual Tumor Size as reported by the pathologist on the final surgical pathology report..

Outcome measures

Measure	Standard (Prone) MRI Tumor Imaging n=26 Participants Comparison of tumor size between standard (prone) MRI imaging and surgical pathology
Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size	0.652 correlation coefficient Interval 0.354 to 0.83

PRIMARY outcome

Timeframe: at time of MRI imaging

Population: 40 pts who had both a prone and a supine MRI measurement of tumor size

Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images

Outcome measures

Measure	Standard (Prone) MRI Tumor Imaging n=40 Participants Comparison of tumor size between standard (prone) MRI imaging and surgical pathology
Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions.	0.789 correlation coefficient Interval 0.634 to 0.884

SECONDARY outcome

Timeframe: after surgery

Population: among 30 pts analyzed, 13 surgeons reported the supine imaging was helpful whereas 17 surgeons reported the imaging was not helpful

Reported as the proportion of surgeons answering yes. Surgeon reported answers to surveys asking if the supine MRI helped in the performance of the surgical procedure.

Outcome measures

Measure	Standard (Prone) MRI Tumor Imaging n=30 Participants Comparison of tumor size between standard (prone) MRI imaging and surgical pathology
The Perceived Benefit Of Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing Breast-conserving Therapy (BCT) In Our Study Patient Population	0.43 proportion of participants Interval 0.255 to 0.626

Adverse Events

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

Dr. Tari King

Dana-Farber/Brigham Cancer Center

Phone: 617-582-8292

Email: tking7@bwh.harvard.edu

Results disclosure agreements

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