Trial Outcomes & Findings for Intra-operative Digital vs. Standard Mammography (NCT NCT01766102)

Last Updated: 2017-08-24

Results Overview

To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

72 participants

Primary outcome timeframe

At the time of the procedure (approximately 1 week after randomization)

Results posted on

2017-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	Intra-operative Mammography Intra-operative Specimen Mammography Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042	Standard Mammography Standard Specimen Mammography Standard Mammography: There is not an added device associated with this arm.
Overall Study STARTED	36	36
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intra-operative Digital vs. Standard Mammography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intra-operative Mammography n=36 Participants Intra-operative Specimen Mammography Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042	Standard Mammography n=36 Participants Standard Specimen Mammography Standard Mammography: There is not an added device associated with this arm.	Total n=72 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	57 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
BMI	27 Kg/m^2 n=5 Participants	25 Kg/m^2 n=7 Participants	26 Kg/m^2 n=5 Participants
Reason for excision Excisional Biopsy	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Reason for excision Atypia	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Reason for excision Invasive Carcinoma/DCIS	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Wire-localization Target Clip	29 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants
Wire-localization Target Mass/ Calcs/ Arch distort	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Anesthesia Type MAC	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Anesthesia Type General	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Axillary Surgery None	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Axillary Surgery SLNB	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Axillary Surgery ALND	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of the procedure (approximately 1 week after randomization)

To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.

Outcome measures

Outcome measures
Measure	Intra-operative Mammography n=36 Participants Intra-operative Specimen Mammography Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042	Standard Mammography n=36 Participants Standard Specimen Mammography Standard Mammography: There is not an added device associated with this arm.
Comparison of Operative Time Savings Procedure Time	48.5 Minutes Interval 17.0 to 138.0	54 Minutes Interval 17.0 to 140.0
Comparison of Operative Time Savings OR Time	68 Minutes Interval 29.0 to 180.0	74 Minutes Interval 35.0 to 177.0

SECONDARY outcome

Timeframe: 2 years

Population: Interpretation of margin status by the surgeon was available for 22 of 36 ISM patients. Interpretation of margin status was also available for 22 of 36 SSM patients.

Assessment of radiographic findings and pathologic findings to determine sensitivity, specificity, positive predictive value, and negative predictive values of intra-operative digital specimen mammography (ISM) and standard specimen mammography for determining margin status. * A true positive (TP) was defined as a positive margin by imaging (ISM or SSM) and pathology * A false positive (FP) was defined as a positive margin by imaging but negative by pathology * A true negative (TN) was defined as a negative margin by both imaging and pathology. * A false negative (FN) was defined as a negative margin by imaging but positive by pathology * The sensitivity \[TP/(TP + FN)\], specificity \[TN/(TN + FP)\], positive predictive value \[TP/ (TP + FP)\], and negative predictive value \[TN/(TN + FN)\] for identification of positive margins were calculated for ISM and SSM.

Outcome measures

Outcome measures
Measure	Intra-operative Mammography n=22 Participants Intra-operative Specimen Mammography Intra-operative Mammography: The patient's breast specimen will be imagine in the operating room in an intra-operative imaging device - Biovision SN #30042	Standard Mammography n=22 Participants Standard Specimen Mammography Standard Mammography: There is not an added device associated with this arm.
Assessment of Radiographic and Pathologic Findings Sensitivity	50 Percent	20 Percent
Assessment of Radiographic and Pathologic Findings Specificity	89 Percent	94 Percent
Assessment of Radiographic and Pathologic Findings Positive Predicitve Value	50 Percent	50 Percent
Assessment of Radiographic and Pathologic Findings Negative Predictive Value	89 Percent	80 Percent

Adverse Events

Intra-operative Mammography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Mammography

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

Michelle Specht, MD

Massachusetts General Hospital

Phone: 617-726-0340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place