BRCA1 Protein, BRCA2 Protein, Breast Neoplasms, Tomosynthesis
Conditions
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.
Interventions
DEVICEStandard mammography
Standard mammography
DEVICEStandard mammography and tomosynthesis
Standard mammography and tomosynthesis
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast Imaging-Reporting And Data System (BI-RADS) scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of additional examinations | Day 30 | Needs for supplementary breast imaging exams and biopsies |
| The number of ultrasound exams | Day 30 | — |
| Total radiation dose | Day 30 | — |
| Criteria for a poor prognosis | Day 1 | 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. |
| Agreement between readers | Day 1 | The reproducibility of the interpretation of tomosynthesis will be assessed with differences of classifications BiRadsT observed between the two radiologists |
| Cumulative incidence of Breast cancer diagnosis | Month 24 | Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation |
| Cost of the diagnostic strategies | Day 30 | — |
Countries
France
Contacts
Primary Contactcedric De Bazelaire, MD PHD
Backup ContactMatthieu Resche-Rigon, MD PHD
Outcome results
None listed