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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

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).

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109-1023
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

outpatient clinic

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visibility of marker clip after placement in suspicious breast lesions.	Within 4 weeks of placement

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: GE Healthcare; Ethicon Endo-Surgery
• Investigators: Principal Investigator: Peter R Eby, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: October 22, 2007
• First Submitted That Met QC Criteria: October 22, 2007
• First Posted (Estimate): October 24, 2007

Study Record Updates

• Last Update Posted (Estimate): December 31, 2008
• Last Update Submitted That Met QC Criteria: December 29, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: ultrasound; cancer; breast; high risk; marker clip
• Other Study ID Numbers: 6263