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Diagnostic Study of Early Breast Cancer Using Ultrasound

This study is not yet open for participant recruitment.
Verified July 2011 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01391039
First received: June 15, 2011
Last updated: July 7, 2011
Last verified: July 2011
History of Changes

June 15, 2011
July 7, 2011
September 2011
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01391039 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Diagnostic Study of Early Breast Cancer Using Ultrasound
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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Ductal Carcinoma In-situ
Drug: Perflutren lipid microsphere
Intravenous injection of 10 microL/kg once prior to ultrasound examination
Other Name: Definity
Experimental: Contrast perfusion and elastography arm
Intravenous injection of microbubble contrast agent and elastography
Intervention: Drug: Perflutren lipid microsphere
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
Contact: Anoma Gunasekara, B.Sc. 416-480-5786 anoma.gunasekara@sunnybrook.ca
Canada
 
NCT01391039
RJ07062011
No
Dr. Roberta Jong, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Not Provided
Principal Investigator: Roberta A Jong, FRCPC Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP