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