Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

Not Applicable

• Conditions: BRCA2 Protein; BRCA1 Protein; Breast Neoplasms; Tomosynthesis
• Interventions: Device: Standard mammography; Device: Standard mammography and tomosynthesis

• Registration Number: NCT02959398
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Status Verified: 2017-11
• Study Start: 2017-11-20
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24
• Primary Completion: 2020-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard mammography	Standard mammography	standard mammography
standard mammography and tomosynthesis	Standard mammography and tomosynthesis	standard mammography and tomosynthesis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Total radiation dose	Day 30
Cost of the diagnostic strategies	Day 30
The number of ultrasound exams	Day 30
Number of additional examinations	Day 30	Needs for supplementary breast imaging exams and biopsies
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.
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

Trial Locations

Locations (2)

hopital Saint-Louis; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France