Breast Cancer, 2D Mammography, 3D Mammography
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