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OpenTrials
Completed

NCT Number: NCT01669148

Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

The primary hypothesis to be tested is:

The detection of breast cancer will be increased with tomosynthesis (3D) imaging

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MGH

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tomosynthesis

Device

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

Device

conventional (2D) imaging (standard mammography)

Primary outcomes

  1. Detection of Breast Cancer (Sensitivity)

    Time frame: up to two years follow up for development of breast cancer

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

    Sensitivity = TP / (TP+FN)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Hologic, Inc.

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Aug 20, 2012
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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