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Study Rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. MRI is considered as the most sensible exam for this staging. However it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. By contrast, Tomosynthesis is performed during the same time than mammography and has a good specificity. Although this modality is very promising, it has not been assessed in a population of consecutive patients.
Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tomosynthesis | Other | Bilateral mammography with 4 views Tomosynthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral mammography with Tomosynthesis | Device | no intervention pre specified to be administered to participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers. | In all sites, Mammography and Tomosynthesis will be standardised and performed according to the Combo mode with 2 views for each breast. Any additional breast lesion assigned a BI-RAD 4 or 5 score after the full staging work-up will be biopsied under the best imaging method. (BIRADS scale : BIRADS 4a or higher is considered to be positive for cancer ) The Gold Standard diagnosis is defined as the final diagnosis at 1 year on the basis of the most severe histopathologic result (surgery, biopsy) for that lesion. A retrospective imaging evaluation of mammography versus Combo mode will be performed for the patients diagnosed with a breast cancer lesion. This retrospective imaging evaluation will be conducted centrally within the assessment committee at the lesion, breast and patient level. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity | Concerning breasts lesions : assessing multicentricity by MG and Combo for the presence of one BI-RADS 4-5 lesions, presence of multifocal BI-RADS 4-5 lesions presence of multicentric BI-RADS 4-5 lesions A retrospective imaging evaluation of mammography versus Combo mode will be performed for the patients diagnosed with a breast cancer lesion. This retrospective imaging evaluation will be conducted centrally within the assessment committee at the lesion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Taourel | UH Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Hospital oh Antony | Antony | 92169 | France | |||
| UH Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30964425 | Derived | Fontaine M, Tourasse C, Pages E, Laurent N, Laffargue G, Millet I, Molinari N, Taourel P. Local Tumor Staging of Breast Cancer: Digital Mammography versus Digital Mammography Plus Tomosynthesis. Radiology. 2019 Jun;291(3):594-603. doi: 10.1148/radiol.2019182457. Epub 2019 Apr 9. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 1 year |
| performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality | concerning Breasts lesions : assessing multifocality by MG and Combo for the presence of one BI-RADS 4-5 lesions, presence of multifocal BI-RADS 4-5 lesions presence of multicentric BI-RADS 4-5 lesions A retrospective imaging evaluation of mammography versus Combo mode will be performed for the patients diagnosed with a breast cancer lesion. This retrospective imaging evaluation will be conducted centrally within the assessment committee at the lesion, breast and patient level. | 1 year |
| Grenoble |
| 34043 |
| France |
| Oscar Lambret Center | Lille | 59000 | France |
| Jean Mermoz Hospital | Lyon | 69008 | France |
| UH Montpellier | Montpellier | 34295 | France |
| Hospital Valenciennes | Valenciennes | 59322 | France |
| D017437 |
| Skin and Connective Tissue Diseases |