Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

Assistance Publique - Hôpitaux de Paris2,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,000

Conditions

Breast Neoplasms Tomosynthesis BRCA1 Protein BRCA2 Protein

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

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.

Time frame: Day 1

Secondary Outcomes

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.

Time frame: Day 1

Number of additional examinations

Needs for supplementary breast imaging exams and biopsies

Time frame: Day 30

The number of ultrasound exams

Time frame: Day 30

Total radiation dose

Time frame: Day 30

Cost of the diagnostic strategies

Time frame: 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

Time frame: Day 1

Cumulative incidence of Breast cancer diagnosis

Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation

Time frame: Month 24

Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts