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The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer


N/A
26 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer


Inclusion Criteria:



GROUP 1

- female of any race and ethnicity

- 35 years or older

- after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will
undergo study imaging within 30 days of routine or diagnostic imaging.

- subject is returning for surveillance imaging after a categorization of a BI-RADS 3
and will undergo study imaging within 30 days of surveillance imaging GROUP 2

- female of any race and ethnicity

- 26 years or older

- subject has completed cancer treatment and is currently categorized as a BI-RADS 3
for surveillance imaging

- subject will undergo study imaging within 30 days of surveillance imaging GROUP 3

- female of any race and ethnicity

- 26 years or older

- subject is currently undergoing cancer treatment and is currently categorized as a
BI-RADS 3 for surveillance imaging OR

- subject will undergo study imaging within 30 days of surveillance imaging

Exclusion Criteria:

- GROUP 1, 2 and 3

- subjects unable or unwilling to participate

- subjects who are unable or unwilling to tolerate compression

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

- subjects who are breastfeeding

Type of Study:

Observational

Study Design:

Observational Model: Case-Crossover, Time Perspective: Prospective

Outcome Measure:

to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Joanne Trapeni, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

WellSpan Health

Authority:

United States: Institutional Review Board

Study ID:

0708023

NCT ID:

NCT00763100

Start Date:

May 2008

Completion Date:

November 2009

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Three dimensional versus two dimensional
  • Breast cancer surveillance
  • Tomosynthesis
  • Breast Neoplasms

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