2D Mammography, 3D Mammography, Breast Cancer
Conditions
Keywords
breast cancer, surveillance, diagnosis, 2D mammography, 3D mammography
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)
Interventions
DEVICEtomosynthesis
2 incidences 3D numeric mammography
DEVICE2D mammography
2 incidences 2D analogic mammography
Sponsors
Centre Oscar Lambret
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| determine the benefit of tomosynthesis for diagnosis | 30 months | number of avoided focused cliches and ultrasound, after tomosynthesis analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| number of additional cancer detected by tomosynthesis | 30 months | number of breast cancer detected through tomosynthesis |
Countries
France
Outcome results
None listed