ETOLE: Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT02959398

Collaborator

(none)

2,000

Enrollment

Locations

Arms

41.3

Anticipated Duration (Months)

1000

Patients Per Site

24.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Tomosynthesis BRCA1 Protein BRCA2 Protein	Device: Standard mammography Device: Standard mammography and tomosynthesis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"

Actual Study Start Date :

Nov 20, 2017

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: standard mammography

standard mammography

Device: Standard mammography

Standard mammography

Experimental: standard mammography and tomosynthesis

standard mammography and tomosynthesis

Device: Standard mammography and tomosynthesis

Standard mammography and tomosynthesis

Outcome Measures

Primary Outcome Measures

Breast Imaging-Reporting And Data System (BI-RADS) scale [Day 1]
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 [Day 1]
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 [Day 30]
Needs for supplementary breast imaging exams and biopsies
The number of ultrasound exams [Day 30]
Total radiation dose [Day 30]
Cost of the diagnostic strategies [Day 30]
Agreement between readers [Day 1]
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 [Month 24]
Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	hopital Saint-Louis	Paris		France	75010
2	Hopital Tenon	Paris		France	75020

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT02959398

Other Study ID Numbers:

P120121

First Posted:

Nov 9, 2016

Last Update Posted:

Nov 24, 2017

Last Verified:

Nov 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 24, 2017