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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 : Completed
First Posted : June 6, 2012
Last Update Posted : March 23, 2018
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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1069 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
Actual Study Start Date : February 24, 2012
Actual Primary Completion Date : March 16, 2017
Actual Study Completion Date : March 16, 2017

Resource links provided by the National Library of Medicine


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



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


Locations
France
Oscar Lambret Center
Lille, France, 59020
Centre Hospitalier - Pavillon Paul Gelé
Roubaix, France, 59100
Centre Hospitalier
Valenciennes, France, 59300
Clinique des Dentellières
Valenciennes, France, 59300
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: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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