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Diagnostic Study of Early Breast Cancer Using Ultrasound

This study has been terminated.
(Low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01391039
First Posted: July 11, 2011
Last Update Posted: November 30, 2015
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.
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
  Purpose
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 Intervention
Ductal Carcinoma In-situ Drug: Perflutren lipid microsphere

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 12
Study Start Date: September 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01391039


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

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01391039     History of Changes
Other Study ID Numbers: RJ07062011
First Submitted: June 15, 2011
First Posted: July 11, 2011
Last Update Posted: November 30, 2015
Last Verified: November 2015

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

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