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Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

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ClinicalTrials.gov Identifier: NCT01669148
Recruitment Status : Completed
First Posted : August 20, 2012
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Thomas J. Brady, M.D., Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Breast Cancer
Interventions: Device: Tomosynthesis
Device: Conventional

  Participant Flow

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

496 enrolled and 426 completed study, but no information available to distinguish study arms:

  1. Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number of participants enrolled in arm is unknown).
  2. Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number of participants enrolled in arm is unknown).

Reporting Groups
  Description
All Study Participants All participants enrolled in study

Participant Flow:   Overall Study
    All Study Participants
STARTED   496 
COMPLETED   426 
NOT COMPLETED   70 



  Baseline Characteristics

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.

496 participants enrolled overall, but no information available to distinguish study arms:

  1. Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number of participants enrolled in arm is unknown).
  2. Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number of participants enrolled in arm is unknown).

Reporting Groups
  Description
All Study Participants All study participants in both arms. 496 enrolled and 426 completed study, but no information available to distinguish study arms.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 496 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      427  86.1% 
>=65 years      69  13.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      496 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   248 


  Outcome Measures

1.  Primary:   Detection of Breast Cancer (Sensitivity)   [ Time Frame: up to two years follow up for development of breast cancer ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas J. Brady, MD
Organization: Massachusetts General Hospital
phone: 6177268294
e-mail: tbrady@mgh.harvard.edu



Responsible Party: Thomas J. Brady, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01669148     History of Changes
Other Study ID Numbers: 2007p-001197
First Submitted: April 30, 2010
First Posted: August 20, 2012
Results First Submitted: April 12, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017