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Intra-operative Digital vs. Standard Mammography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766102
First Posted: January 11, 2013
Last Update Posted: August 24, 2017
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.
Information provided by (Responsible Party):
Michelle Specht, Massachusetts General Hospital
Results First Submitted: June 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Breast Cancer
Interventions: Procedure: Intra-operative Mammography
Procedure: Standard Mammography

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intra-operative Mammography

Intra-operative Specimen Mammography

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

Standard Mammography

Standard Specimen Mammography

Standard Mammography: There is not an added device associated with this arm.


Participant Flow:   Overall Study
    Intra-operative Mammography   Standard Mammography
STARTED   36   36 
COMPLETED   36   36 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intra-operative Mammography

Intra-operative Specimen Mammography

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

Standard Mammography

Standard Specimen Mammography

Standard Mammography: There is not an added device associated with this arm.

Total Total of all reporting groups

Baseline Measures
   Intra-operative Mammography   Standard Mammography   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   36   72 
Age 
[Units: Years]
Median (Full Range)
 59 
 (36 to 79) 
 57 
 (40 to 78) 
 58 
 (36 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      36 100.0%      36 100.0%      72 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   36   36   72 
BMI [1] 
[Units: Kg/m^2]
Median (Full Range)
 27 
 (18 to 38) 
 25 
 (18 to 46) 
 26 
 (18 to 46) 
[1] Body Mass Index is a weight to height ratio calculated by dividing someone's weight in Kg by the square of someone's height in meters.
Reason for excision [1] 
[Units: Participants]
Count of Participants
     
Excisional Biopsy   4   3   7 
Atypia   7   5   12 
Invasive Carcinoma/DCIS   25   28   53 
[1]

The indication for the excision:

  • An Excisional biopsy is a procedure where the entire abnormality or area of interest is removed.
  • Atypical Hyperplasia is a precancerous condition that is defined by an atypical accumulation of abnormal cells in the breast.
  • Ductal carcinoma in situ (DCIS) is the presence of abnormal cells inside a milk duct in the breast. DCIS is considered the earliest form of breast cancer.
  • Invasive Carcinoma is a cancer that began growing in a duct in the breast and has since invaded the fatty tissue of the breast outside of the duct.
Wire-localization Target [1] 
[Units: Participants]
Count of Participants
     
Clip   29   33   62 
Mass/ Calcs/ Arch distort   7   3   10 
[1] A thin wire is inserted down to the target area of breast so that during surgery the surgeon can follow the guide wire down to the target area and remove the wire and the tissue around it. A clip is a marker that is placed in the breast during a biopsy that can be used a target for wire insertion. Mass means a solid mass in the breast. Calculated means that the target location was either manually or computer calculated. Architectural distortion (arch distort) is when a mammogram shows tethering or indentation of breast tissue but without an apparent associated mass.
Anesthesia Type [1] 
[Units: Participants]
Count of Participants
     
MAC   24   21   45 
General   12   15   27 
[1] The type of anesthesia used during the procedure. Monitored anesthesia care (MAC) is when a patient undergoes local anesthesia together with sedation and analgesia. General anesthesia is anesthesia that affects the whole body and usually induces a loss of consciousness.
Axillary Surgery [1] 
[Units: Participants]
Count of Participants
     
None   15   16   31 
SLNB   20   20   40 
ALND   1   0   1 
[1]

Type of axillary lymph node surgery

  • SLNB= Sentinel Lymph Node Biopsy
  • ALND= Axillary Lymph Node Dissection


  Outcome Measures
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1.  Primary:   Comparison of Operative Time Savings   [ Time Frame: At the time of the procedure (approximately 1 week after randomization) ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michelle Specht, MD
Organization: Massachusetts General Hospital
phone: 617-726-0340
e-mail: MSPECHT@mgh.harvard.edu



Responsible Party: Michelle Specht, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01766102     History of Changes
Other Study ID Numbers: 12-107
First Submitted: January 8, 2013
First Posted: January 11, 2013
Results First Submitted: June 2, 2017
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017