EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 2000
- Locations
- 2
- Primary Endpoint
- Breast Imaging-Reporting And Data System (BI-RADS) scale
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Breast Imaging-Reporting And Data System (BI-RADS) scale
Time Frame: Day 1
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.
Secondary Outcomes
- Total radiation dose(Day 30)
- Cost of the diagnostic strategies(Day 30)
- The number of ultrasound exams(Day 30)
- Number of additional examinations(Day 30)
- Criteria for a poor prognosis(Day 1)
- Agreement between readers(Day 1)
- Cumulative incidence of Breast cancer diagnosis(Month 24)