Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

Study Overview
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Brief Summary
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This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)

Official Title
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Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

Conditions
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Breast Cancer, 2D Mammography, 3D Mammography

Intervention / Treatment
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* Device: tomosynthesis
* Device: 2D mammography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: breast cancer histologically proven<br>Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment | Device: tomosynthesis<br>* 2 incidences 3D numeric mammography<br>Device: 2D mammography<br>* 2 incidences 2D analogic mammography<br>|
| Active Comparator: surveillance of a treated breast cancer<br>surveillance of patient already treated for breast cancer must have annual mammography | Device: tomosynthesis<br>* 2 incidences 3D numeric mammography<br>Device: 2D mammography<br>* 2 incidences 2D analogic mammography<br>|
| Active Comparator: diagnosis of a detected anomaly<br>patient addressed for diagnosis of a detected anomaly | Device: tomosynthesis<br>* 2 incidences 3D numeric mammography<br>Device: 2D mammography<br>* 2 incidences 2D analogic mammography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the benefit of tomosynthesis for diagnosis | number of avoided focused cliches and ultrasound, after tomosynthesis analysis | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine best incidence of realization | face, medial side or oblique | 30 months | 
| measurement of breast irradiation | comparison of tomosynthesis irradiation and focused cliches irradiation | 30 months | 
| evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast |  | 30 months | 
| number of additional cancer detected by tomosynthesis | number of breast cancer detected through tomosynthesis | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, surveillance, diagnosis, 2D mammography, 3D mammography