Diagnostic Study of Early Breast Cancer Using Ultrasound

Sunnybrook Health Sciences Centre

Status: Terminated

Conditions: Ductal Carcinoma In-situ

Treatments: Drug: Perflutren lipid microsphere

Study type: Interventional

Funder types: Other

Identifiers

NCT01391039

RJ07062011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Contrast perfusion and elastography arm

Experimental group

Description:

Intravenous injection of microbubble contrast agent and elastography

Treatment:

Drug: Perflutren lipid microsphere