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Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis.
The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard mammography | Active Comparator | standard mammography |
|
| standard mammography and tomosynthesis | Experimental | standard mammography and tomosynthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard mammography | Device | Standard mammography |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Breast Imaging-Reporting And Data System (BI-RADS) scale | The primary evaluation parameter will be the classification error of tumors according to the BiRads scale obtained by mammography (BiRadsM) and by tomosynthesis (BiRadsT) according to the gold standard. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Criteria for a poor prognosis | The visibility (presence or absence) of signs of poor prognosis criteria. We will compare the visibility of poor prognosis criteria seen on mammography + ultrasound and seen on tomosynthesis with synthetic mammography + ultrasound. | Day 1 |
| Number of additional examinations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| cedric De Bazelaire, MD PHD | Contact | 142499133 | +33 | cedric.de-bazelaire@aphp.fr |
| Matthieu Resche-Rigon, MD PHD | Contact | 142499742 | +33 | matthieu.resche-rigon@univ-paris-diderot.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hopital Saint-Louis | Recruiting | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| C563980 | Fanconi Anemia, Complementation Group D1 |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Standard mammography and tomosynthesis |
| Device |
Standard mammography and tomosynthesis |
|
Needs for supplementary breast imaging exams and biopsies |
| Day 30 |
| The number of ultrasound exams | Day 30 |
| Total radiation dose | Day 30 |
| Cost of the diagnostic strategies | Day 30 |
| Agreement between readers | The reproducibility of the interpretation of tomosynthesis will be assessed with differences of classifications BiRadsT observed between the two radiologists | Day 1 |
| Cumulative incidence of Breast cancer diagnosis | Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation | Month 24 |
| Hopital Tenon | Recruiting | Paris | 75020 | France |
|
| D017437 |
| Skin and Connective Tissue Diseases |