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"

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasms; BRCA1 Protein; BRCA2 Protein; Tomosynthesis
• Intervention / Treatment: Device: Standard mammography; Device: Standard mammography and tomosynthesis

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Hôpital Saint-Louis
    • Contact: matthieu resche-rigon; Phone Number: +33 142499742; Email: matthieu.resche-rigon@univ-paris-diderot.fr
  • Paris, France, 75020
    • Recruiting
    • Hopital Tenon
    • Contact: Isabelle THOMASSIN- NAGGARA, Pr; Email: isabelle.thomassin@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard mammography	Device: Standard mammography; Standard mammography
Experimental: standard mammography and tomosynthesis	Device: Standard mammography and tomosynthesis; Standard mammography and tomosynthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
Number of additional examinations	Needs for supplementary breast imaging exams and biopsies	Day 30
The number of ultrasound exams		Day 30
Total radiation dose		Day 30
Cost of the diagnostic strategies		Day 30
Agreement between readers	The reproducibility of the interpretation of tomosynthesis will be assessed with differences of classifications BiRadsT observed between the two radiologists	Day 1
Cumulative incidence of Breast cancer diagnosis	Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation	Month 24

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: P120121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No