Back to resultsAssessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis (TOMOSEIN)
Primary Purpose
Breast Cancer, 2D Mammography, 3D Mammography
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tomosynthesis
2D mammography
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring breast cancer, surveillance, diagnosis, 2D mammography, 3D mammography
Eligibility 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
Sites / Locations
- Oscar Lambret Center
- Centre Hospitalier - Pavillon Paul Gelé
- Centre Hospitalier
- Clinique des Dentellières
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
breast cancer histologically proven
surveillance of a treated breast cancer
diagnosis of a detected anomaly
Arm Description
Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment
surveillance of patient already treated for breast cancer must have annual mammography
patient addressed for diagnosis of a detected anomaly
Outcomes
Primary Outcome Measures
determine the benefit of tomosynthesis for diagnosis
number of avoided focused cliches and ultrasound, after tomosynthesis analysis
Secondary Outcome Measures
determine best incidence of realization
face, medial side or oblique
measurement of breast irradiation
comparison of tomosynthesis irradiation and focused cliches irradiation
evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast
number of additional cancer detected by tomosynthesis
number of breast cancer detected through tomosynthesis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01612650
Brief Title
Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
Acronym
TOMOSEIN
Official Title
Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 24, 2012 (Actual)
Primary Completion Date
March 16, 2017 (Actual)
Study Completion Date
March 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, 2D Mammography, 3D Mammography
Keywords
breast cancer, surveillance, diagnosis, 2D mammography, 3D mammography
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1069 (Actual)
8. Arms, Groups, and Interventions
Arm Title
breast cancer histologically proven
Arm Type
Active Comparator
Arm Description
Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment
Arm Title
surveillance of a treated breast cancer
Arm Type
Active Comparator
Arm Description
surveillance of patient already treated for breast cancer must have annual mammography
Arm Title
diagnosis of a detected anomaly
Arm Type
Active Comparator
Arm Description
patient addressed for diagnosis of a detected anomaly
Intervention Type
Device
Intervention Name(s)
tomosynthesis
Intervention Description
2 incidences 3D numeric mammography
Intervention Type
Device
Intervention Name(s)
2D mammography
Intervention Description
2 incidences 2D analogic mammography
Primary Outcome Measure Information:
Title
determine the benefit of tomosynthesis for diagnosis
Description
number of avoided focused cliches and ultrasound, after tomosynthesis analysis
Time Frame
30 months
Secondary Outcome Measure Information:
Title
determine best incidence of realization
Description
face, medial side or oblique
Time Frame
30 months
Title
measurement of breast irradiation
Description
comparison of tomosynthesis irradiation and focused cliches irradiation
Time Frame
30 months
Title
evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast
Time Frame
30 months
Title
number of additional cancer detected by tomosynthesis
Description
number of breast cancer detected through tomosynthesis
Time Frame
30 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie TAIEB, MD
Organizational Affiliation
Oscar Lambret Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oscar Lambret Center
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospitalier - Pavillon Paul Gelé
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Centre Hospitalier
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Facility Name
Clinique des Dentellières
City
Valenciennes
ZIP/Postal Code
59300
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
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