Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions
ETOLE
EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"
1 other identifier
interventional
2,000
1 country
2
Brief Summary
Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis. The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedStudy Start
First participant enrolled
November 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedNovember 24, 2017
November 1, 2017
2.4 years
November 7, 2016
November 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Breast Imaging-Reporting And Data System (BI-RADS) scale
The primary evaluation parameter will be the classification error of tumors according to the BiRads scale obtained by mammography (BiRadsM) and by tomosynthesis (BiRadsT) according to the gold standard.
Day 1
Secondary Outcomes (7)
Criteria for a poor prognosis
Day 1
Number of additional examinations
Day 30
The number of ultrasound exams
Day 30
Total radiation dose
Day 30
Cost of the diagnostic strategies
Day 30
- +2 more secondary outcomes
Study Arms (2)
standard mammography
ACTIVE COMPARATORstandard mammography
standard mammography and tomosynthesis
EXPERIMENTALstandard mammography and tomosynthesis
Interventions
Standard mammography and tomosynthesis
Eligibility Criteria
You may qualify if:
- Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5)
- Patient over 18 years old
- Signed informed consent
You may not qualify if:
- Patients at high risk of breast cancer, mutations BRCA 1 (BReast CAncer gene 1) or BRCA 2 (BReast CAncer gene 2) carriers, Li Fraumeni, or history of thoracic radiation will be excluded because of their greater sensitivity to ionizing radiation.
- Patient unable to give informed consent for physical, mental, or legal reasons.
- Patient not affiliated with French Social Security Insurance.
- Patient under treatment for breast cancer.
- When mammography is not recommended according to good practice by the French Health Authority (HAS).
- Pregnant patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
hopital Saint-Louis
Paris, 75010, France
Hopital Tenon
Paris, 75020, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2016
First Posted
November 9, 2016
Study Start
November 20, 2017
Primary Completion
May 1, 2020
Study Completion
May 1, 2021
Last Updated
November 24, 2017
Record last verified: 2017-11