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Tomosynthesis in Screening Mammography

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. Identifier: NCT01086241
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : March 11, 2016
Hologic, Inc.
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.

Condition or disease Intervention/treatment Phase
Breast Density >25% Procedure: 2D Mammogram Procedure: Tomosynthesis Not Applicable

Detailed Description:
We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped < 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography
Study Start Date : May 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Active Comparator: A: routine 2D mammogram
Subject receives regular 2D mammogram.
Procedure: 2D Mammogram
Those patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.

Active Comparator: B: Routine Mammogram + tomosynthesis
Routine Mammogram and tomosynthesis
Procedure: Tomosynthesis
Those patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.

Primary Outcome Measures :
  1. Interpretation Time of Scan [ Time Frame: Within 1 month of receiving scan ]

Secondary Outcome Measures :
  1. Recall Rates [ Time Frame: 6 month intervals for 2 years after initial scan ]
  2. Discomfort Scale [ Time Frame: Immediately after the subject receives scan ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines.
  • Prior mammogram report indicating ≥ 25% breast density.

Exclusion Criteria:

  • Prior mammogram report indicating <25% breast density.
  • Breast implants
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01086241

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Canada, Alberta
Alberta Screen Test
Edmonton, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
Hologic, Inc.
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Study Chair: Aalo Bistritz, MD Cross Cancer Institute
Principal Investigator: Aalo Bistritz, MD Cross Cancer Institute
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Responsible Party: AHS Cancer Control Alberta Identifier: NCT01086241    
Other Study ID Numbers: DX-TOM-001 25232
DX-TOM-001 25232
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016
Keywords provided by AHS Cancer Control Alberta:
Breast Neoplasms
Prevention and Control