Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions (ETOLE)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: BRCA2 Protein; Tomosynthesis; Breast Neoplasms; BRCA1 Protein

Treatments: Device: Standard mammography; Device: Standard mammography and tomosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02959398

P120121

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

standard mammography

Active Comparator group

Description:

standard mammography

Treatment:

Device: Standard mammography

standard mammography and tomosynthesis

Experimental group

Description:

standard mammography and tomosynthesis

Treatment:

Device: Standard mammography and tomosynthesis