- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01391039
Diagnostic Study of Early Breast Cancer Using Ultrasound
November 26, 2015 updated by: Sunnybrook Health Sciences Centre
Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contrast perfusion and elastography arm
Intravenous injection of microbubble contrast agent and elastography
|
Intravenous injection of 10 microL/kg once prior to ultrasound examination
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
The participant will be followed up till the results of the biopsy, an expected average of 3 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The participant will be followed up till the results of the biopsy, an expected average of 3 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Roberta A Jong, FRCPC, Sunnybrook Health Sciences Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
June 15, 2011
First Submitted That Met QC Criteria
July 7, 2011
First Posted (Estimate)
July 11, 2011
Study Record Updates
Last Update Posted (Estimate)
November 30, 2015
Last Update Submitted That Met QC Criteria
November 26, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJ07062011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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