Intra-operative Digital vs. Standard Mammography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01766102
Recruitment Status : Completed
First Posted : January 11, 2013
Results First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Information provided by (Responsible Party):
Michelle Specht, Massachusetts General Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Intra-operative Mammography Procedure: Standard Mammography Phase 4

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  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Comparison of Intra-Operative Digital Specimen Mammography to Standard Specimen Mammography
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

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 Name: Biovision SN # 30042

Active Comparator: Standard Mammography
Standard Specimen Mammography
Procedure: Standard Mammography
There is not an added device associated with this arm.

Primary Outcome Measures :
  1. Comparison of Operative Time Savings [ Time Frame: 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.

Secondary Outcome Measures :
  1. Assessment of Radiographic and Pathologic Findings [ Time Frame: 2 years ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01766102

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Michelle Specht, MD Massachusetts General Hospital

Responsible Party: Michelle Specht, Principal Investigator, Massachusetts General Hospital Identifier: NCT01766102     History of Changes
Other Study ID Numbers: 12-107
First Posted: January 11, 2013    Key Record Dates
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Michelle Specht, Massachusetts General Hospital: