Intra-operative Digital vs. Standard Mammography

This study is not yet open for participant recruitment.
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

January 8, 2013
January 9, 2013
January 2013
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01766102 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • 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
  • Procedure: Standard Mammography
    There is not an added device associated with this arm.
  • Active Comparator: Intra-operative Mammography
    Intra-operative Specimen Mammography
    Intervention: Procedure: Intra-operative Mammography
  • Active Comparator: Standard Mammography
    Standard Specimen Mammography
    Intervention: Procedure: Standard Mammography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
75
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: MIchelle Specht, MD 617-726-0340 mspecht@partners.org
United States
 
NCT01766102
12-107
No
Michelle Specht, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Michelle Specht, MD Massachusetts General Hospital
Massachusetts General Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP