Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis (TOMOSEIN)

Centre Oscar Lambret

Status: Completed

Conditions: Breast Cancer; 2D Mammography; 3D Mammography

Treatments: Device: tomosynthesis; Device: 2D mammography

Study type: Interventional

Funder types: Other

Identifiers

NCT01612650

2011-002051-34 (Other Identifier)

TOMOSEIN-1104

Details and patient eligibility

About

This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)

Enrollment: 1,069 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly
• age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)
• breast size suitable for detector size
• possible prior mastectomy
• security social covered
• signed informed consent

Exclusion criteria

• breast implant
• high genetic risk (mutation)
• under justice measures
• breast feeding or pregnant woman

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,069 participants in 3 patient groups

breast cancer histologically proven

Active Comparator group

Description:

Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment

Treatment:

Device: tomosynthesis

Device: 2D mammography

surveillance of a treated breast cancer

Active Comparator group

Description:

surveillance of patient already treated for breast cancer must have annual mammography

Treatment:

Device: tomosynthesis

Device: 2D mammography

diagnosis of a detected anomaly

Active Comparator group

Description:

patient addressed for diagnosis of a detected anomaly

Treatment:

Device: tomosynthesis

Device: 2D mammography