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
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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