Sonographic Visibility of Breast Biopsy Marker Clips Up to 4 Weeks After Placement

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

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to determine how long collagen based marker clips remain visible by ultrasound after placement in suspicious breast lesions and if collagen based marker clips can be reliably identified in the operating room and serve as effective guidance for surgical removal of high risk or malignant breast lesions.

Detailed Description

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Many breast cancers and other breast lesions are discovered as a palpable abnormality by patients or their providers during a breast exam. Diagnostic imaging and biopsy of these lesions may reveal high-risk or malignant findings. These palpable lesions can be removed in the operating room by the surgeon using touch as guidance. However, there are many lesions discovered by screening examinations that surgeons cannot palpate. When this occurs, a radiologist will percutaneously place a wire or wires at the site of the breast lesion using sonographic or mammographic guidance. The surgeon then uses the wires as a guide for complete and successful resection of the lesion.

New marker devices have been developed that are sonographically visible. They consist of the standard mammographically visible metallic clip surrounded by a sonographically visible collagen plug. It is hypothesized that radiologists and surgeons can effectively localize the clip with intra-operative ultrasound and then resect the lesion. If so, the pre-operative wire localization procedure could be eliminated. This could improve the patient experience while saving time and money by reducing the number of invasive procedures from 3 (biopsy, wire-localization and operation) to 2 (biopsy and operation).

Conditions

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Breast Cancer

Keywords

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breast cancer ultrasound high risk marker clip

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with suspicious breast lesions that have undergone biopsy and marker clip placement within 28 days (4 weeks) of pre-operative consultation visit.
* Patients or their legal representative must be able to provide written informed consent.
* Patients must be over 18 years old.

Exclusion Criteria

* Under the age of 18 years
* Unable to give written informed consent
* Patients will be excluded if the clip was placed more than 4 weeks prior to their pre-operative appointment or wire-localization.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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University of Washington/SCCA

Principal Investigators

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Peter R Eby, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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6263

Identifier Type: -

Identifier Source: org_study_id