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

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ClinicalTrials.gov Identifier: NCT01612650
Recruitment Status : Unknown
Verified June 2014 by Centre Oscar Lambret.
Recruitment status was:  Recruiting
First Posted : June 6, 2012
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Breast Cancer 2D Mammography 3D Mammography Device: tomosynthesis Device: 2D mammography Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1172 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
Study Start Date : February 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. determine the benefit of tomosynthesis for diagnosis [ Time Frame: 30 months ]
    number of avoided focused cliches and ultrasound, after tomosynthesis analysis


Secondary Outcome Measures :
  1. determine best incidence of realization [ Time Frame: 30 months ]
    face, medial side or oblique

  2. measurement of breast irradiation [ Time Frame: 30 months ]
    comparison of tomosynthesis irradiation and focused cliches irradiation

  3. evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast [ Time Frame: 30 months ]
  4. number of additional cancer detected by tomosynthesis [ Time Frame: 30 months ]
    number of breast cancer detected through tomosynthesis



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01612650     History of Changes
Other Study ID Numbers: TOMOSEIN-1104
2011-002051-34 ( Other Identifier: IDRCB number (ANSM) )
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

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