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Clinical Trials/NCT01391039
NCT01391039
Terminated
N/A

Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer

Sunnybrook Health Sciences Centre1 site in 1 country12 target enrollmentSeptember 2011

Overview

Phase
N/A
Intervention
Perflutren lipid microsphere
Conditions
Ductal Carcinoma In-situ
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
12
Locations
1
Primary Endpoint
Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Contrast perfusion and elastography arm

Intravenous injection of microbubble contrast agent and elastography

Intervention: Perflutren lipid microsphere

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Measurement of transient shear wave elastography .(The participant will be followed up till the results of the biopsy, an expected average of 3 months.)

Study Sites (1)

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