Comparison of Two Types of Biopsy in Patients With Breast Lesions

Study Overview
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Brief Summary
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RATIONALE: Biopsy is the removal of cells or tissue for examination under a microscope. It is not yet known which type of breast biopsy is more effective for diagnosing breast lesions. PURPOSE: Randomized diagnostic trial to compare the effectiveness of two different types of biopsy in patients who have breast lesions that cannot be felt upon examination.

Detailed Description
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OBJECTIVES: I. Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time and tissue loss in patients with nonpalpable breast lesions. II. Compare the cost effectiveness of these diagnostic methods in these patients. III. Demonstrate that radioactive seed localization allows for elimination of specimen x-ray in these patients. IV. Demonstrate that radioactive seeds may be placed safely for 1-7 days prior to surgical removal in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two diagnostic arms. Arm I: Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram. Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.

Official Title
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Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Needle localized breast biopsy with specimen x-ray
* Procedure: Low dose radioactive seed followed by surgery and mammogram


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Suspicious nonpalpable breast lesion requiring breast biopsy for diagnosis OR Nonpalpable breast lesion that is not amenable to core needle biopsy or advanced breast biopsy instrumentation (ABBI) excision Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I: Radioactive Seed Localized Breast Biopsy<br>Arm I: Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram. | Procedure: Low dose radioactive seed followed by surgery and mammogram<br>* either iodine I 125 or palladium Pd 103<br>|
| Active Comparator: Arm II: Needle Localized Breast Biopsy<br>Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray. | Procedure: Needle localized breast biopsy with specimen x-ray<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Loss Rates for Each Arm | Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on tissue loss in patients with nonpalpable breast lesions. | 18 months | 
| Operative Time Rates in Each Group | Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time in patients with nonpalpable breast lesions. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events for Each Group | Review of adverse events utilizing Common Toxicity Criteria (CTC) V3. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biopsy, radioactive seed, nonpalpable lesions