Comparison of Two Types of Biopsy in Patients With Breast Lesions

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Low dose radioactive seed followed by surgery and mammogram; Procedure: Needle localized breast biopsy with specimen x-ray

• Registration Number: NCT00006031
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2000-07-05
• Primary Completion: 2001-07
• Study First Submitted QC: 2004-04-01
• Study First Posted: 2004-04-02
• Study Completion: 2006-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I: Radioactive Seed Localized Breast Biopsy	Low dose radioactive seed followed by surgery and mammogram	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: Needle Localized Breast Biopsy	Needle localized breast biopsy with specimen x-ray	Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.

Primary Outcome Measures

Name	Time	Method
Tissue Loss Rates for Each Arm	18 months	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.
Operative Time Rates in Each Group	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events for Each Group	18 months	Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States