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Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis


Phase 2
40 Years
N/A
Open (Enrolling)
Female
Breast Cancer, 2D Mammography, 3D Mammography

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Trial Information

Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis


Inclusion Criteria:



- woman with breast cancer histologically proven (group 1), on surveillance of a
treated breast cancer (group 2) or diagnosis of an detected anomaly

- age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)

- breast size suitable for detector size

- possible prior mastectomy

- security social covered

- signed informed consent

Exclusion Criteria:

- breast implant

- high genetic risk (mutation)

- under justice measures

- breast feeding or pregnant woman

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

determine the benefit of tomosynthesis for diagnosis

Outcome Description:

number of avoided focused cliches and ultrasound, after tomosynthesis analysis

Outcome Time Frame:

30 months

Safety Issue:

No

Principal Investigator

Sophie TAIEB, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oscar Lambret Center

Authority:

France: Committee for the Protection of Personnes

Study ID:

TOMOSEIN-1104

NCT ID:

NCT01612650

Start Date:

February 2012

Completion Date:

August 2014

Related Keywords:

  • Breast Cancer
  • 2D Mammography
  • 3D Mammography
  • breast cancer
  • surveillance
  • diagnosis
  • 2D mammography
  • 3D mammography
  • Breast Neoplasms

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