Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

Study Overview
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Brief Summary
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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.

Official Title
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Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Bilateral mammography with Tomosynthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women at least 40 years old Subject with a new lesion recommended for biopsy, whatever the modality which detected the lesion (clinical examination, mammography, tomosynthesis, US, or MRI) Exclusion Criteria: Subjects with BRCA mutation or at high genetic risk Subjects who have breast implants Personal history of breast cancer Subjects who are pregnant or who think they may be pregnant Subjects who are breast-feeding Subjects who are unable or unwilling to tolerate study constraints Subjects unable or unwilling to undergo informed consent Subject with no rights from the national health insurance programme

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tomosynthesis<br>Bilateral mammography with 4 views Tomosynthesis | Device: Bilateral mammography with Tomosynthesis<br>* no intervention pre specified to be administered to participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tomosynthesis, Mammography, Breast cancer