Intra-operative Digital vs. Standard Mammography

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Michelle Specht, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01766102
First received: January 8, 2013
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Breast Cancer
Procedure: Intra-operative Mammography
Procedure: Standard Mammography
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Comparison of Intra-Operative Digital Specimen Mammography to Standard Specimen Mammography

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Comparison of Operative Time Savings [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography. This will be reported as minutes in the operating room.


Secondary Outcome Measures:
  • Assessment of Radiographic and Pathologic Findings [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the rate of positive margin of a lumpectomy specimen based on final pathology for patients treated with intra-operative specimen radiograph compared with standard compression mammography. This will be report as a percent of patients in each arm.


Estimated Enrollment: 75
Study Start Date: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intra-operative Mammography
Intra-operative Specimen Mammography
Procedure: Intra-operative Mammography
The patient's breast specimen will be imagine 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766102

Contacts
Contact: MIchelle Specht, MD 617-726-0340 mspecht@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Michelle Specht, MD    617-726-0340    mspecht@partners.org   
Principal Investigator: Michelle Specht, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Michelle Specht, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Michelle Specht, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01766102     History of Changes
Other Study ID Numbers: 12-107
Study First Received: January 8, 2013
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Mammography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014