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Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography


N/A
35 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

image quality

Outcome Description:

image quality with standard mammography vs tomosynthesis

Outcome Time Frame:

concurrent assessment of image quality with up to two year follow up for development of breast cancer

Safety Issue:

No

Principal Investigator

Elizabeth A Rafferty, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

2007p-001197

NCT ID:

NCT01669148

Start Date:

November 2007

Completion Date:

October 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • imaging
  • Breast Neoplasms

Name

Location

MGHBoston, Massachusetts  02114