Diagnostic Study of Early Breast Cancer Using Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01391039
Recruitment Status : Terminated (Low recruitment)
First Posted : July 11, 2011
Last Update Posted : November 30, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ductal Carcinoma In-situ Drug: Perflutren lipid microsphere Not Applicable

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  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer
Study Start Date : September 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Perflutren

Arm Intervention/treatment
Experimental: Contrast perfusion and elastography arm
Intravenous injection of microbubble contrast agent and elastography
Drug: Perflutren lipid microsphere
Intravenous injection of 10 microL/kg once prior to ultrasound examination
Other Name: Definity

Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01391039

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Principal Investigator: Roberta A Jong, FRCPC Sunnybrook Health Sciences Centre

Responsible Party: Sunnybrook Health Sciences Centre Identifier: NCT01391039     History of Changes
Other Study ID Numbers: RJ07062011
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

Keywords provided by Sunnybrook Health Sciences Centre:
Ductal Carcinoma In-situ
Contrast Ultrasound

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ