Clinical Trial: Diagnostic Study of Early Breast Cancer Using Ultrasound

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer

Brief Summary: This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.

Detailed Summary: Women who have imaging findings suggestive of DCIS, who are having breast ultrasound and who are candidates for surgery will be eligible. They will receive a contrast-enhanced breast ultrasound after the intravenous injection of a microbubble contrast agent which will show the microvascularity. A subset of women will also have ultrasound elastography performed of the abnormality to evaluate its stiffness.
Sponsor: Sunnybrook Health Sciences Centre

Current Primary Outcome: Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound. [ Time Frame: The participant will be followed up till the results of the biopsy, an expected average of 3 months. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Measurement of transient shear wave elastography . [ Time Frame: The participant will be followed up till the results of the biopsy, an expected average of 3 months. ]

The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers.


Original Secondary Outcome: Same as current

Information By: Sunnybrook Health Sciences Centre

Dates:
Date Received: June 15, 2011
Date Started: September 2011
Date Completion:
Last Updated: November 26, 2015
Last Verified: November 2015