Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

NCT01881880 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2024-05-29

No results posted yet for this study

Summary

Study Rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. MRI is considered as the most sensible exam for this staging. However it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. By contrast, Tomosynthesis is performed during the same time than mammography and has a good specificity. Although this modality is very promising, it has not been assessed in a population of consecutive patients.

Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.

Conditions

Interventions

DEVICE

Bilateral mammography with Tomosynthesis

no intervention pre specified to be administered to participants

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Patrice Taourel · UH Montpellier

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-19
Primary Completion
2015-08-31
Completion
2015-12-31

Countries

  • France

Study Locations

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Entities

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 NCT01881880 on ClinicalTrials.gov