Diagnostic Study of Early Breast Cancer Using Ultrasound

Ductal Carcinoma In-situ Clinical Trial

Official title:

Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01391039
• Other study ID #: RJ07062011
• Status: Terminated
• Phase: N/A
• First received: June 15, 2011
• Last updated: November 26, 2015
• Start date: September 2011
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma In-situ

Intervention

Drug:
• Perflutren lipid microsphere
Intravenous injection of 10 microL/kg once prior to ultrasound examination

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.		The participant will be followed up till the results of the biopsy, an expected average of 3 months.	No
Secondary	Measurement of transient shear wave elastography .	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.	No