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

• ClinicalTrials.gov Identifier: NCT02956473
• Recruitment Status: Completed
• First Posted: November 6, 2016
• Results First Posted: March 12, 2024
• Last Update Posted: March 12, 2024
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Tari King, MD, Dana-Farber Cancer Institute

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Breast Cancer
• Interventions: Device: Supine MRI; Other: Neoadjuvant Therapy (NAT); Device: Ultrasound; Device: Mammography; Procedure: Standard of Care; Device: Standard MRI
• Enrollment: 57

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Supine MRI
Arm/Group Description	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
Period Title: Overall Study
Started	57
Completed	57
Not Completed	0

Baseline Characteristics

Arm/Group Title		Supine MRI
Arm/Group Description		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 Number of Baseline Participants		57
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	57 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	48 84.2%
	>=65 years	9 15.8%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	57 participants
		52; (21 to 80)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	57 participants
	Female	57 100.0%
	Male	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	57 participants
	Hispanic or Latino	3 5.3%
	Not Hispanic or Latino	53 93.0%
	Unknown or Not Reported	1 1.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	57 participants
	American Indian or Alaska Native	0 0.0%
	Asian	3 5.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	5 8.8%
	White	48 84.2%
	More than one race	0 0.0%
	Unknown or Not Reported	1 1.8%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	57 participants
		57 100.0%

Outcome Measures

1. Primary Outcome

Title	Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size
Description	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.
Time Frame	time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Standard (Prone) MRI Tumor Imaging
Arm/Group Description:	Comparison of tumor size between standard (prone) MRI imaging and surgical pathology
Overall Number of Participants Analyzed	38
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: correlation coefficient
	0.635; (0.395 to 0.794)

2. Primary Outcome

Title	Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size
Description	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..
Time Frame	time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Supine MRI and Pathologic Tumor Size
Arm/Group Description:	Patients with both supine MRI measurements and pathologic tumor size measurements
Overall Number of Participants Analyzed	26
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: correlation coefficient
	0.652; (0.354 to 0.830)

3. Primary Outcome

Title	Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions.
Description	Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images
Time Frame	at time of MRI imaging

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Patients With Imaging in Both the Prone and Supine Positions
Arm/Group Description:	comparison of maximum tumor dimension as measured on prone MRI imaging versus supine MRI imaging
Overall Number of Participants Analyzed	40
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: correlation coefficient
	0.789; (0.634 to 0.884)

4. Secondary Outcome

Title	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
Description	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.
Time Frame	after surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Breast Conserving Surgery Patients
Arm/Group Description:	Patients having supine MRI imaging and proceeding with breast conserving surgery
Overall Number of Participants Analyzed	30
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: proportion of participants
	0.43; (.255 to .626)

Adverse Events

Time Frame	1 month
Adverse Event Reporting Description	The definition does not differ from the clinicaltirals.gov definitions.
Arm/Group Title	Supine MRI
Arm/Group Description	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
All-Cause Mortality
	Supine MRI
	Affected / at Risk (%)
Total	0/17 (0.00%)
Serious Adverse Events
	Supine MRI
	Affected / at Risk (%)
Total	0/17 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Supine MRI
	Affected / at Risk (%)
Total	0/17 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Tari King
• Organization: Dana-Farber/Brigham Cancer Center
• Phone: 617-582-8292
• EMail: tking7@bwh.harvard.edu

• Responsible Party: Tari King, MD, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT02956473
• Other Study ID Numbers: 16-277
• First Submitted: November 3, 2016
• First Posted: November 6, 2016
• Results First Submitted: October 18, 2023
• Results First Posted: March 12, 2024
• Last Update Posted: March 12, 2024