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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
Enrollment 496

Recruitment Details  
Pre-assignment Details

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).
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants enrolled in study
Period Title: Overall Study
Started 496
Completed 426
Not Completed 70
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants in both arms. 496 enrolled and 426 completed study, but no information available to distinguish study arms.
Overall Number of Baseline Participants 496
Hide Baseline Analysis Population Description
496 participants enrolled overall, but no information available to distinguish study arms: Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number of participants enrolled in arm is unknown). Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number of participants enrolled in arm is unknown).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 496 participants
<=18 years
0
   0.0%
Between 18 and 65 years
427
  86.1%
>=65 years
69
  13.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 496 participants
Female
496
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 496 participants
248
1.Primary Outcome
Title Detection of Breast Cancer (Sensitivity)
Hide Description

Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):

Sensitivity = TP / (TP+FN)

Time Frame up to two years follow up for development of breast cancer
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Conventional + Tomosynthesis First Then Tomo Alone 1 mo. Later Tomosynthesis Alone First Then Conventional+Tomo 1 mo. Later
Hide Arm/Group Description:

Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).

Conventional: conventional (2D) imaging (standard mammography)

Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).

Conventional: conventional (2D) imaging (standard mammography)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description

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.

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

  1. Conventional+Tomosynthesis First Then Tomo alone 1 mo. Later (number enrolled in arm is unknown).
  2. Tomosynthesis alone First Then Conventional+Tomo 1 mo. Later (number enrolled in arm is unknown).
 
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants enrolled in the study
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/0 
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.
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
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