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Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions (ETOLE)

Primary Purpose

Breast Neoplasms, Tomosynthesis, BRCA1 Protein

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standard mammography
Standard mammography and tomosynthesis
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5)
  • Patient over 18 years old
  • Signed informed consent

Exclusion Criteria:

  • 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.

Sites / Locations

  • hopital Saint-LouisRecruiting
  • Hopital TenonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard mammography

standard mammography and tomosynthesis

Arm Description

standard mammography

standard mammography and tomosynthesis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Criteria for a poor prognosis
The visibility (presence or absence) of signs of poor prognosis criteria. We will compare the visibility of poor prognosis criteria seen on mammography + ultrasound and seen on tomosynthesis with synthetic mammography + ultrasound.
Number of additional examinations
Needs for supplementary breast imaging exams and biopsies
The number of ultrasound exams
Total radiation dose
Cost of the diagnostic strategies
Agreement between readers
The reproducibility of the interpretation of tomosynthesis will be assessed with differences of classifications BiRadsT observed between the two radiologists
Cumulative incidence of Breast cancer diagnosis
Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation

Full Information

First Posted
November 7, 2016
Last Updated
November 22, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02959398
Brief Title
Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions
Acronym
ETOLE
Official Title
EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Tomosynthesis, BRCA1 Protein, BRCA2 Protein

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard mammography
Arm Type
Active Comparator
Arm Description
standard mammography
Arm Title
standard mammography and tomosynthesis
Arm Type
Experimental
Arm Description
standard mammography and tomosynthesis
Intervention Type
Device
Intervention Name(s)
Standard mammography
Intervention Description
Standard mammography
Intervention Type
Device
Intervention Name(s)
Standard mammography and tomosynthesis
Intervention Description
Standard mammography and tomosynthesis
Primary Outcome Measure Information:
Title
Breast Imaging-Reporting And Data System (BI-RADS) scale
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Criteria for a poor prognosis
Description
The visibility (presence or absence) of signs of poor prognosis criteria. We will compare the visibility of poor prognosis criteria seen on mammography + ultrasound and seen on tomosynthesis with synthetic mammography + ultrasound.
Time Frame
Day 1
Title
Number of additional examinations
Description
Needs for supplementary breast imaging exams and biopsies
Time Frame
Day 30
Title
The number of ultrasound exams
Time Frame
Day 30
Title
Total radiation dose
Time Frame
Day 30
Title
Cost of the diagnostic strategies
Time Frame
Day 30
Title
Agreement between readers
Description
The reproducibility of the interpretation of tomosynthesis will be assessed with differences of classifications BiRadsT observed between the two radiologists
Time Frame
Day 1
Title
Cumulative incidence of Breast cancer diagnosis
Description
Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation
Time Frame
Month 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5) Patient over 18 years old Signed informed consent Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cedric De Bazelaire, MD PHD
Phone
142499133
Ext
+33
Email
cedric.de-bazelaire@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu Resche-Rigon, MD PHD
Phone
142499742
Ext
+33
Email
matthieu.resche-rigon@univ-paris-diderot.fr
Facility Information:
Facility Name
hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
matthieu resche-rigon
Phone
142499742
Ext
+33
Email
matthieu.resche-rigon@univ-paris-diderot.fr
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle THOMASSIN- NAGGARA, Pr
Email
isabelle.thomassin@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

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