Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
Conditions
Breast Cancer - 2D Mammography - 3D Mammography
Conditions: Keywords
breast cancer, surveillance, diagnosis, 2D mammography, 3D mammography
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Intervention
Name: tomosynthesis Type: Device
Name: 2D mammography Type: Device
Overall Status
Recruiting
Summary
This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 40 Years
Gender: Female
Criteria: 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
Locations
Oscar Lambret Center
Lille, France
Status: Recruiting
Contact: Sophie TAIEB, MD - +33 (0)3.20.29.59.18 - s-taieb@o-lambret.fr
Centre Hospitalier - Pavillon Paul Gelé
Roubaix, France
Status: Recruiting
Contact: Marie-Aurélie DELESALLE, MD - 33 3 20 99 32 48 - delesalle.marie@gmail.com
Centre Hospitalier
Valenciennes, France
Status: Recruiting
Contact: Trung LE THANH, MD - 33
Clinique des Dentellières
Valenciennes, France
Status: Recruiting
Contact: Sandra SEVERIN, MD - 33 327147500 - sandra.severin-fontana@wanadoo.fr
Start Date
February 2012
Completion Date
August 2014
Sponsors
Centre Oscar Lambret
Source
Centre Oscar Lambret
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page