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Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tomosynthesis
Conventional
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, imaging

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • Any ethnic origin
  • No contraindication for routine bilateral mammography

Exclusion Criteria:

Potential subjects with any of the following will not be enrolled in the study:

  • Any contraindications to mammographic screening, including, but not limited to:
  • Significant existing breast trauma
  • Under the age of 30 at the time of consent
  • Breast Implants

  • Prior Surgeries

    • Unable to understand and execute written informed consent
    • Pregnant
    • Lactating

Sites / Locations

  • MGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional + Tomosynthesis

Tomosynthesis alone

Arm Description

conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.

tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later.

Outcomes

Primary Outcome Measures

Detection of Breast Cancer (Sensitivity)
Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)

Secondary Outcome Measures

Full Information

First Posted
April 30, 2010
Last Updated
May 19, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Hologic, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01669148
Brief Title
Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
Official Title
Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Hologic, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary hypothesis to be tested is: The detection of breast cancer will be increased with tomosynthesis (3D) imaging
Detailed Description
The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
496 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional + Tomosynthesis
Arm Type
Active Comparator
Arm Description
conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.
Arm Title
Tomosynthesis alone
Arm Type
Active Comparator
Arm Description
tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later.
Intervention Type
Device
Intervention Name(s)
Tomosynthesis
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Conventional
Intervention Description
conventional (2D) imaging (standard mammography)
Primary Outcome Measure Information:
Title
Detection of Breast Cancer (Sensitivity)
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Any ethnic origin No contraindication for routine bilateral mammography Exclusion Criteria: Potential subjects with any of the following will not be enrolled in the study: Any contraindications to mammographic screening, including, but not limited to: Significant existing breast trauma Under the age of 30 at the time of consent Breast Implants Prior Surgeries Unable to understand and execute written informed consent Pregnant Lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Rafferty, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

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