Status:

TERMINATED

Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging

Lead Sponsor:

University Hospital, Montpellier

Conditions:

Breast Cancer

Eligibility:

FEMALE

40+ years

Phase:

NA

Brief 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 specifici...

Eligibility Criteria

Inclusion

  • Women at least 40 years old
  • Subject with a new lesion recommended for biopsy, whatever the modality which detected the lesion (clinical examination, mammography, tomosynthesis, US, or MRI)

Exclusion

  • Subjects with BRCA mutation or at high genetic risk
  • Subjects who have breast implants
  • Personal history of breast cancer
  • Subjects who are pregnant or who think they may be pregnant
  • Subjects who are breast-feeding
  • Subjects who are unable or unwilling to tolerate study constraints
  • Subjects unable or unwilling to undergo informed consent
  • Subject with no rights from the national health insurance programme

Key Trial Info

Start Date :

November 19 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2015

Estimated Enrollment :

424 Patients enrolled

Trial Details

Trial ID

NCT01881880

Start Date

November 19 2012

End Date

December 1 2015

Last Update

May 29 2024

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Private Hospital oh Antony

Antony, France, 92169

2

UH Grenoble

Grenoble, France, 34043

3

Oscar Lambret Center

Lille, France, 59000

4

Jean Mermoz Hospital

Lyon, France, 69008