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Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions


N/A
21 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions


Inclusion Criteria:



- patients who have been referred to a breast ultrasound because of a positive physical
palpation and/or positive mammograms and/or positive ultrasound and/or positive MRI.

- female

- age 21 or older

- provide informed consent

Exclusion Criteria:

- Women who are unwilling or unable to provide informed consent

- Women with breast implants

- Women with superficial lesions or lesions on skin (with the most superficial surface
of the lesion within 5 mm of the skin surface)

- Women who are pregnant or breastfeeding

- Women who are undergoing chemotherapy or radiotherapy for any cancer

- Women with previous breast conserving surgery on the breast of interest Note:
Previous excision of a benign lesion 4 cm or more away from the suspected lesion
does not constitute an exclusion criterion.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Assess the potential value of adding shear wave Elastography to a conventional ultrasound exam while imaging breast lesions

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David O Cosgrove, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hammersmith Hospital, London, UK

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

A00152-53

NCT ID:

NCT00716482

Start Date:

July 2008

Completion Date:

June 2010

Related Keywords:

  • Breast Neoplasms
  • breast
  • lesion
  • ultrasound
  • BI-RADS
  • malignancy
  • women
  • Breast Neoplasms
  • Neoplasms

Name

Location

University of Southern California - LAC+USC Medical Center, OPD Rm 3P61 Los Angeles, California  90033
Sally Jobe Breast Center Denver, Colorado  80206
Yale Medical Center, Department of Diagnostic Radiology New Haven, Connecticut  06510
Northwestern Memorial Hospital, Dept. of Radiology Chicago, Illinois  60611
Boston Medical Center, Radiology Boston, Massachusetts  02118
Thomas Jefferson Medical Center, Department of Radiology Philadelphia, Pennsylvania  19107