Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

Status: Completed
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
France
Oscar Lambret Center
Lille
Centre Hospitalier - Pavillon Paul Gelé
Roubaix
Centre Hospitalier
Valenciennes
Clinique des Dentellières
Valenciennes
Time Frame
Start Date: February 24, 2012
Completion Date: March 16, 2017
Participants
Target number of participants: 1069
Treatments
Active Comparator: breast cancer histologically proven
Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment
Active Comparator: surveillance of a treated breast cancer
surveillance of patient already treated for breast cancer must have annual mammography
Active Comparator: diagnosis of a detected anomaly
patient addressed for diagnosis of a detected anomaly
Authors
Trung LE THANH, Marie-Aurélie DELESALLE, Céline CHAVERON, Gwendoline LEVY, Matthieu FAIVRE-PIERRET, Sylvain DEDEIRE, Isabelle DAMAREY-FELDMANN, Luc CEUGNART, Hervé BERCEZ, Edouard PONCELET, Thomas BOULANGER, Aniela RUSU, Sophie TAIEB, Armelle RENAUD, Caroline BECK, Gwenaelle POULIQUEN, Florence BACHELLE, Nathalie ROCOURT, Nicolas LAURENT, Corinne JUMELLE, Delphine FREMAUX-ISRAEL, Theodora SERB, Parta ETASSAMI, Sandra SEVERIN, Sophie GAVAND, Perrine FOUVEZ
Related Therapeutic Areas
Sponsors
Leads: Centre Oscar Lambret

This content was sourced from clinicaltrials.gov

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