Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

Study Overview
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Brief Summary
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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.

Official Title
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EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : ETOLE

Conditions
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Breast Neoplasms, Tomosynthesis, BRCA1 Protein, BRCA2 Protein

Intervention / Treatment
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* Device: Standard mammography
* Device: Standard mammography and tomosynthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5) Patient over 18 years old Signed informed consent Exclusion Criteria: Patients at high risk of breast cancer, mutations BRCA 1 (BReast CAncer gene 1) or BRCA 2 (BReast CAncer gene 2) carriers, Li Fraumeni, or history of thoracic radiation will be excluded because of their greater sensitivity to ionizing radiation. Patient unable to give informed consent for physical, mental, or legal reasons. Patient not affiliated with French Social Security Insurance. Patient under treatment for breast cancer. When mammography is not recommended according to good practice by the French Health Authority (HAS). Pregnant patient.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard mammography<br>standard mammography | Device: Standard mammography<br>* Standard mammography<br>|
| Experimental: standard mammography and tomosynthesis<br>standard mammography and tomosynthesis | Device: Standard mammography and tomosynthesis<br>* Standard mammography and tomosynthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |