NCT01612650

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,069

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2017

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

5.1 years

First QC Date

June 4, 2012

Last Update Submit

March 21, 2018

Conditions

Breast Cancer2D Mammography3D Mammography

Keywords

breast cancersurveillancediagnosis2D mammography3D mammography

Outcome Measures

Primary Outcomes (1)

  • determine the benefit of tomosynthesis for diagnosis

    number of avoided focused cliches and ultrasound, after tomosynthesis analysis

    30 months

Secondary Outcomes (4)

  • determine best incidence of realization

    30 months

  • measurement of breast irradiation

    30 months

  • evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast

    30 months

  • number of additional cancer detected by tomosynthesis

    30 months

Study Arms (3)

breast cancer histologically proven

ACTIVE COMPARATOR

Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment

Device: tomosynthesisDevice: 2D mammography

surveillance of a treated breast cancer

ACTIVE COMPARATOR

surveillance of patient already treated for breast cancer must have annual mammography

Device: tomosynthesisDevice: 2D mammography

diagnosis of a detected anomaly

ACTIVE COMPARATOR

patient addressed for diagnosis of a detected anomaly

Device: tomosynthesisDevice: 2D mammography

Interventions

tomosynthesisDEVICE

2 incidences 3D numeric mammography

breast cancer histologically provendiagnosis of a detected anomalysurveillance of a treated breast cancer
2D mammographyDEVICE

2 incidences 2D analogic mammography

breast cancer histologically provendiagnosis of a detected anomalysurveillance of a treated breast cancer

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • breast implant
  • high genetic risk (mutation)
  • under justice measures
  • breast feeding or pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Oscar Lambret Center

Lille, 59020, France

Location

Centre Hospitalier - Pavillon Paul Gelé

Roubaix, 59100, France

Location

Centre Hospitalier

Valenciennes, 59300, France

Location

Clinique des Dentellières

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Breast NeoplasmsDisease

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Sophie TAIEB, MD

    Oscar Lambret Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

February 24, 2012

Primary Completion

March 16, 2017

Study Completion

March 16, 2017

Last Updated

March 23, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)