Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

Not Applicable

Completed

• Conditions: Breast Cancer; 2D Mammography; 3D Mammography
• Interventions: Device: tomosynthesis; Device: 2D mammography

• Registration Number: NCT01612650
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-24
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-06
• Primary Completion: 2017-03-16
• Study Completion: 2017-03-16
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1069

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
breast cancer histologically proven	2D mammography	Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment
diagnosis of a detected anomaly	2D mammography	patient addressed for diagnosis of a detected anomaly
surveillance of a treated breast cancer	2D mammography	surveillance of patient already treated for breast cancer must have annual mammography
surveillance of a treated breast cancer	tomosynthesis	surveillance of patient already treated for breast cancer must have annual mammography
breast cancer histologically proven	tomosynthesis	Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment
diagnosis of a detected anomaly	tomosynthesis	patient addressed for diagnosis of a detected anomaly

Primary Outcome Measures

Name	Time	Method
determine the benefit of tomosynthesis for diagnosis	30 months	number of avoided focused cliches and ultrasound, after tomosynthesis analysis

Secondary Outcome Measures

Name	Time	Method
number of additional cancer detected by tomosynthesis	30 months	number of breast cancer detected through tomosynthesis
determine best incidence of realization	30 months	face, medial side or oblique
measurement of breast irradiation	30 months	comparison of tomosynthesis irradiation and focused cliches irradiation
evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast	30 months

Trial Locations

Locations (4)

Centre Hospitalier - Pavillon Paul Gelé; 🇫🇷 Roubaix, France

Oscar Lambret Center; 🇫🇷 Lille, France

Centre Hospitalier; 🇫🇷 Valenciennes, France

Clinique des Dentellières; 🇫🇷 Valenciennes, France