Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
Not Applicable
Completed
- Conditions
- Breast Cancer2D Mammography3D Mammography
- Registration Number
- NCT01612650
- Lead Sponsor
- Centre Oscar Lambret
- Brief Summary
This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1069
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method determine the benefit of tomosynthesis for diagnosis 30 months number of avoided focused cliches and ultrasound, after tomosynthesis analysis
- Secondary Outcome Measures
Name Time Method number of additional cancer detected by tomosynthesis 30 months number of breast cancer detected through tomosynthesis
determine best incidence of realization 30 months face, medial side or oblique
measurement of breast irradiation 30 months comparison of tomosynthesis irradiation and focused cliches irradiation
evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast 30 months
Trial Locations
- Locations (4)
Oscar Lambret Center
🇫🇷Lille, France
Centre Hospitalier - Pavillon Paul Gelé
🇫🇷Roubaix, France
Centre Hospitalier
🇫🇷Valenciennes, France
Clinique des Dentellières
🇫🇷Valenciennes, France
Oscar Lambret Center🇫🇷Lille, France