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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
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer

Resource links provided by NLM:

Drug Information available for: Perflutren
U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
    The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers.


Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391039

Contacts
Contact: Anoma Gunasekara, B.Sc. 416-480-5786 anoma.gunasekara@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet recruiting
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

No publications provided

Responsible Party: Dr. Roberta Jong, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01391039     History of Changes
Other Study ID Numbers: RJ07062011
Study First Received: June 15, 2011
Last Updated: July 7, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 22, 2013