Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1069 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-24

Study Completion Date

2017-03-16

Brief Summary

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

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Detailed Description

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Conditions

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Breast Cancer 2D Mammography 3D Mammography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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breast cancer histologically proven

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

Group Type ACTIVE_COMPARATOR

tomosynthesis

Intervention Type DEVICE

2 incidences 3D numeric mammography

2D mammography

Intervention Type DEVICE

2 incidences 2D analogic mammography

surveillance of a treated breast cancer

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

Group Type ACTIVE_COMPARATOR

tomosynthesis

Intervention Type DEVICE

2 incidences 3D numeric mammography

2D mammography

Intervention Type DEVICE

2 incidences 2D analogic mammography

diagnosis of a detected anomaly

patient addressed for diagnosis of a detected anomaly

Group Type ACTIVE_COMPARATOR

tomosynthesis

Intervention Type DEVICE

2 incidences 3D numeric mammography

2D mammography

Intervention Type DEVICE

2 incidences 2D analogic mammography

Interventions

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tomosynthesis

2 incidences 3D numeric mammography

Intervention Type DEVICE

2D mammography

2 incidences 2D analogic mammography

Intervention Type DEVICE

Eligibility Criteria

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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