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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548392
• Other study ID #: 6263
• Status: Completed
• Phase: N/A
• First received: October 22, 2007
• Last updated: December 29, 2008
• Start date: May 2007
• Est. completion date: September 2008

Study information

• Verified date: December 2008
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Ethicon Endo-Surgery, GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visibility of marker clip after placement in suspicious breast lesions.		Within 4 weeks of placement	No