Back to resultsDiagnostic Study of Early Breast Cancer Using Ultrasound
Primary Purpose
Ductal Carcinoma In-situ
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Perflutren lipid microsphere
Sponsored by
About this trial
This is an interventional diagnostic trial for Ductal Carcinoma In-situ focused on measuring Ductal Carcinoma In-situ, Contrast Ultrasound, Microinvasion, Elastography
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
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast perfusion and elastography arm
Arm Description
Intravenous injection of microbubble contrast agent and elastography
Outcomes
Primary Outcome Measures
Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.
Secondary Outcome Measures
Measurement of transient shear wave elastography .
The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers.
Full Information
NCT ID
NCT01391039
First Posted
June 15, 2011
Last Updated
November 26, 2015
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01391039
Brief Title
Diagnostic Study of Early Breast Cancer Using Ultrasound
Official Title
Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Carcinoma In-situ
Keywords
Ductal Carcinoma In-situ, Contrast Ultrasound, Microinvasion, Elastography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contrast perfusion and elastography arm
Arm Type
Experimental
Arm Description
Intravenous injection of microbubble contrast agent and elastography
Intervention Type
Drug
Intervention Name(s)
Perflutren lipid microsphere
Other Intervention Name(s)
Definity
Intervention Description
Intravenous injection of 10 microL/kg once prior to ultrasound examination
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Measurement of transient shear wave elastography .
Description
The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers.
Time Frame
The participant will be followed up till the results of the biopsy, an expected average of 3 months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta A Jong, FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Study of Early Breast Cancer Using Ultrasound
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