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A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study


Phase 0
35 Years
80 Years
Open (Enrolling by invite only)
Female
Fibrocystic Disease of Breast, Breast Cancer

Thank you

Trial Information

A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study


Inclusion Criteria:



- Female

- Any race or ethnicity

- At least 35 years old

- Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center

Exclusion Criteria:

- Unable or unwilling to undergo informed consent

- Subjects who have breast implants

- Subjects who are unable or unwilling to tolerate compression

- Subjects who are pregnant or who think they may be pregnant

- Subjects who are currently lactating

- Men

- Women less than 35 years old

- Women greater than 80 years old

- Subjects whose breasts are larger than the tomosynthesis detector

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Dione Farria, MD MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

DBT11212008

NCT ID:

NCT00826488

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Fibrocystic Disease of Breast
  • Breast Cancer
  • Breast Cancer
  • Mammography
  • Benign masses
  • Breast Lump
  • Breast Biopsy
  • Breast Mass
  • Breast Neoplasms
  • Breast Diseases
  • Cystic Fibrosis
  • Fibrocystic Breast Disease

Name

Location

JoAnne Knight Breast Center, Barnes HospitalSt. Louis, Missouri  63110