Intra-operative Digital vs. Standard Mammography

A Comparison of Intra-Operative Digital Specimen Mammography to Standard Specimen Mammography

A breast biopsy in the operating room may be needed in up to 15% of patients with an abnormality on mammogram. When an abnormality is present but there is no palpable mass, the abnormality must be localized with a wire before going to the operating room. This technique is also used when a breast cancer is present but there is no mass, in order to perform a targeted lumpectomy. Once the abnormality is surgically removed, the specimen with the wire is taken to the breast imaging department for a specimen x-ray to ensure that the targeted abnormality is present within the specimen. If the abnormality is close to the edge of the specimen, additional tissue is often removed.

A newer method for evaluating the specimen is to perform imaging in the operating room. Portable digital mammography units are available for this purpose. The Biovision digital specimen mammography system is FDA-approved and currently in use in over 200 centers in the United States. Several studies have shown that intra-operative digital mammography is as accurate as standard specimen mammography and takes less time to perform. It may also decrease the chance of having to go back to the operating room to take more breast tissue after lumpectomy because of cancer cells near teh margin(s) of the specimen on final pathology. Having to go back to the operating room to take more tissue is called a re-excision.

The purpose of this study is to compare standard specimen mammography to intra-operative specimen mammography to quantify potential operating room time savings and to determine if the use of intra-operative specimen mammography decreases re-excision rates. We aim to see if intra-operative specimen mammography is more efficient and if it decreases re-excision rates.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Intra-operative Mammography; Procedure: Standard Mammography

Detailed Description

Before the research starts patients will undergo some screening procedures to determine if patients are eligible to participate. This includes a medical history and an assessment of the patient's breast abnormality by mammogram and/or ultrasound and/or breast MRI. Patients will not need to undergo any extra procedures apart from those needed by the patient's surgeon to plan the patient's breast surgery. If the screening process shows that a patient is eligible to participate in this research study, the patient will be enrolled and the study will proceed on the day of surgery. If a patient does not meet the eligibility criteria the patient will not be able to participate in this research study.

Patients will be assigned to one of two arms of this study on the day of your surgery. Because no one knows which of the breast specimen imaging options is best, patients will be "randomized" into one of the study groups: the Standard Specimen Mammography arm or, the Intra-operative Specimen Mammography arm. Randomization means that the patient is put into a group by chance. It is like flipping a coin. Neither the patient nor the surgeon will choose what group the patient will be in.

If the patient is in the Standard Specimen Mammography arm, the patient's breast specimen (biopsy or lumpectomy) will be taken to the Breast Imaging department for a mammogram, which is the way breast specimens are typically imaged. If the patient is in the Intra-Operative Specimen Mammography arm, the patient's breast specimen will be imaged right in the operating room at the time of the surgery. The patient's images will also be linked to the Breast Imaging department, so the radiologist can confirm the surgeon's findings.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Newly diagnosed with a breast abnormality undergoing an excisional biopsy with wire localization or newly diagnosed with invasive breast cancer or ductal carcinoma undergoing a lumpectomy with wire localization
• Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

• Recurrent breast cancer
• Palpable masses not requiring wire localization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intra-operative Mammography; Intra-operative Specimen Mammography	Procedure: Intra-operative Mammography; The patient's breast specimen will be imaged in the operating room in an intra-operative imaging device - Biovision SN #30042; Other Names: Biovision SN # 30042
Active Comparator: Standard Mammography; Standard Specimen Mammography	Procedure: Standard Mammography; There is not an added device associated with this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Operative Time Savings	To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.	At the time of the procedure (approximately 1 week after randomization)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Radiographic and Pathologic Findings	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.	2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Michelle Specht, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Actual): August 24, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Mammography
• Other Study ID Numbers: 12-107

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes