Diagnostic Study of Early Breast Cancer Using Ultrasound

Not Applicable

Terminated

• Conditions: Ductal Carcinoma In-situ
• Interventions: Drug: Perflutren lipid microsphere

• Registration Number: NCT01391039
• Lead Sponsor: Sunnybrook Health Sciences Centre

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 Description

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.

Study Timeline

• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Study Start: 2011-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-26
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• A woman with imaging signs suggesting a diagnosis of DCIS who is scheduled for ultrasound and a biopsy is eligible for the study.
• At least 18 years of age

Exclusion Criteria

• Pregnant or possibly pregnant or breast feeding
• Unable to provide informed consent
• Drug or multiple allergies
• Known cardiac shunts
• Known cardiac or chronic pulmonary disease
• Hypersensitivity to perflutren

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast perfusion and elastography arm	Perflutren lipid microsphere	Intravenous injection of microbubble contrast agent and elastography

Primary Outcome Measures

Name	Time	Method
Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.	The participant will be followed up till the results of the biopsy, an expected average of 3 months.

Secondary Outcome Measures

Name	Time	Method
Measurement of transient shear wave elastography .	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.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada