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Diagnostic Study of Early Breast Cancer Using Ultrasound

NCT ID: NCT01391039

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ductal Carcinoma In-situ

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Contrast perfusion and elastography arm

Intravenous injection of microbubble contrast agent and elastography

Group Type EXPERIMENTAL

Perflutren lipid microsphere

Intervention Type DRUG

Intravenous injection of 10 microL/kg once prior to ultrasound examination

Interventions

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Perflutren lipid microsphere

Intravenous injection of 10 microL/kg once prior to ultrasound examination

Intervention Type DRUG

Other Intervention Names

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Definity

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roberta A Jong, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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RJ07062011

Identifier Type: -

Identifier Source: org_study_id