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Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

NCT02959398 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2017-11-24

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms
  • Tomosynthesis
  • BRCA1 Protein
  • BRCA2 Protein

Interventions

DEVICE

Standard mammography

Standard mammography

DEVICE

Standard mammography and tomosynthesis

Standard mammography and tomosynthesis

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2020-05-31
Completion
2021-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02959398 on ClinicalTrials.gov