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

This study is currently recruiting participants.
Verified June 2012 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01612650
First received: June 4, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  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
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         
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
Study First Received: June 4, 2012
Last Updated: June 4, 2012
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 April 22, 2014