Intra-operative Digital vs. Standard Mammography

NCT01766102 | Completed Phase 4 Results DMC FDA Device

• 1 other identifier: 12-107
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Mammography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of Radiographic and Pathologic Findings

  2 years

Study Arms (2)

Intra-operative Mammography

ACTIVE COMPARATOR

Intra-operative Specimen Mammography

Procedure: Intra-operative Mammography

Standard Mammography

ACTIVE COMPARATOR

Standard Specimen Mammography

Procedure: Standard Mammography

Interventions

Intra-operative Mammography PROCEDURE

The patient's breast specimen will be imaged in the operating room in an intra-operative imaging device - Biovision SN #30042

Also known as: Biovision SN # 30042

Intra-operative Mammography

Standard Mammography PROCEDURE

There is not an added device associated with this arm.

Standard Mammography

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Recurrent breast cancer
• Palpable masses not requiring wire localization

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Michelle Specht, MD
• Organization: Massachusetts General Hospital

MSPECHT@mgh.harvard.edu

617-726-0340

Study Officials

• Michelle Specht, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 11, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 24, 2017
• Results First Posted: August 24, 2017

Record last verified: 2017-07

Locations

US (1)