Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

Breast Neoplasms Clinical Trial

— ETOLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02959398
• Other study ID #: P120121
• Status: Recruiting
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 22, 2017
• Start date: November 20, 2017
• Est. completion date: May 2021

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: cedric De Bazelaire, MD PHD
• Phone: 142499133
• Email: cedric.de-bazelaire[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• BRCA1 Protein
• BRCA2 Protein
• Breast Neoplasms
• Tomosynthesis

Intervention

Device:
• Standard mammography
Standard mammography
• Standard mammography and tomosynthesis
Standard mammography and tomosynthesis

Locations

Country	Name	City	State
France	hopital Saint-Louis	Paris
France	Hopital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of additional examinations	Needs for supplementary breast imaging exams and biopsies	Day 30
Secondary	The number of ultrasound exams		Day 30
Secondary	Total radiation dose		Day 30
Secondary	Cost of the diagnostic strategies		Day 30
Secondary	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
Secondary	Cumulative incidence of Breast cancer diagnosis	Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation	Month 24