Diagnostic Study of Early Breast Cancer Using Ultrasound
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer|
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Contrast perfusion and elastography arm
Intravenous injection of microbubble contrast agent and elastography
Drug: Perflutren lipid microsphere
Intravenous injection of 10 microL/kg once prior to ultrasound examination
Other Name: Definity
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391039
|Contact: Anoma Gunasekara, B.Sc.||firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Roberta A Jong, FRCPC||Sunnybrook Health Sciences Centre|