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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01612650
First received: June 4, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Breast Cancer
2D Mammography
3D Mammography
Device: tomosynthesis
Device: 2D mammography
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • determine the benefit of tomosynthesis for diagnosis [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    number of avoided focused cliches and ultrasound, after tomosynthesis analysis


Secondary Outcome Measures:
  • determine best incidence of realization [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    face, medial side or oblique

  • measurement of breast irradiation [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    comparison of tomosynthesis irradiation and focused cliches irradiation

  • evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • number of additional cancer detected by tomosynthesis [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    number of breast cancer detected through tomosynthesis


Estimated Enrollment: 1172
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: breast cancer histologically proven
Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment
Device: tomosynthesis
2 incidences 3D numeric mammography
Device: 2D mammography
2 incidences 2D analogic mammography
Active Comparator: surveillance of a treated breast cancer
surveillance of patient already treated for breast cancer must have annual mammography
Device: tomosynthesis
2 incidences 3D numeric mammography
Device: 2D mammography
2 incidences 2D analogic mammography
Active Comparator: diagnosis of a detected anomaly
patient addressed for diagnosis of a detected anomaly
Device: tomosynthesis
2 incidences 3D numeric mammography
Device: 2D mammography
2 incidences 2D analogic mammography

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612650

Contacts
Contact: Yvette VENDEL +33 (0)3.20.29.59.40 y-vendel@o-lambret.fr

Locations
France
Oscar Lambret Center Recruiting
Lille, France, 59020
Contact: Sophie TAIEB, MD    +33 (0)3.20.29.59.18    s-taieb@o-lambret.fr   
Principal Investigator: Sophie TAIEB, MD         
Sub-Investigator: Luc CEUGNART, MD         
Sub-Investigator: Céline CHAVERON, MD         
Sub-Investigator: Florence BACHELLE, MD         
Sub-Investigator: Corinne JUMELLE, MD         
Sub-Investigator: Nathalie ROCOURT, MD         
Sub-Investigator: Gwenaelle POULIQUEN, MD         
Sub-Investigator: Matthieu FAIVRE-PIERRET, MD         
Sub-Investigator: Hervé BERCEZ, MD         
Sub-Investigator: Armelle RENAUD, MD         
Sub-Investigator: Thomas BOULANGER, MD         
Sub-Investigator: Caroline BECK, MD         
Centre Hospitalier - Pavillon Paul Gelé Recruiting
Roubaix, France, 59100
Contact: Marie-Aurélie DELESALLE, MD    33 3 20 99 32 48    delesalle.marie@gmail.com   
Principal Investigator: Marie-Aurélie DELESALLE, MD         
Sub-Investigator: Delphine FREMAUX-ISRAEL, MD         
Sub-Investigator: Perrine FOUVEZ, MD         
Centre Hospitalier Recruiting
Valenciennes, France, 59300
Contact: Trung LE THANH, MD    33      
Sub-Investigator: Trung LE THANH, MD         
Sub-Investigator: Gwendoline LEVY, MD         
Sub-Investigator: Nicolas LAURENT, MD         
Sub-Investigator: Edouard PONCELET, MD         
Sub-Investigator: Theodora SERB, MD         
Sub-Investigator: Aniela RUSU, MD         
Clinique des Dentellières Recruiting
Valenciennes, France, 59300
Contact: Sandra SEVERIN, MD    33 327147500    sandra.severin-fontana@wanadoo.fr   
Principal Investigator: Sandra SEVERIN, MD         
Sub-Investigator: Sophie GAVAND, MD         
Sub-Investigator: Isabelle DAMAREY-FELDMANN, MD         
Sub-Investigator: Parta ETASSAMI, MD         
Sub-Investigator: Sylvain DEDEIRE, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Sophie TAIEB, MD Oscar Lambret Center
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01612650     History of Changes
Other Study ID Numbers: TOMOSEIN-1104, 2011-002051-34
Study First Received: June 4, 2012
Last Updated: June 20, 2014
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Centre Oscar Lambret:
breast cancer
surveillance
diagnosis
2D mammography
3D mammography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014