Clinical trial NCT00548392: Sonographic Visibility of Breast Biopsy Marker Clips Up to 4 Weeks After Placement
Official title: Sonographic Visibility of Breast Biopsy Marker Clips Up to 4 Weeks After Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast
cancer
ultrasound
high risk
marker clip
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
name: GE Healthcare
First posted: 2007-10-24
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient clinic

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Visibility of marker clip after placement in suspicious breast lesions.
timeFrame: Within 4 weeks of placement
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: University of Washington
name: Peter R Eby, MD
role: PRINCIPAL_INVESTIGATOR
References: