Comparison of Two Types of Biopsy in Patients With Breast Lesions

NCT00006031 | Completed

• 2 other identifiers: MCC-12114NCI-G00-1808
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

biopsy; radioactive seed; nonpalpable lesions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of Participants with Adverse Events for Each Group

  18 months

Study Arms (2)

I: Radioactive Seed Localized Breast Biopsy

ACTIVE COMPARATOR

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

Arm II: Needle Localized Breast Biopsy

ACTIVE COMPARATOR

Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.

Procedure: Needle localized breast biopsy with specimen x-ray

Interventions

Needle localized breast biopsy with specimen x-ray PROCEDURE

Arm II: Needle Localized Breast Biopsy

Low dose radioactive seed followed by surgery and mammogram PROCEDURE

either iodine I 125 or palladium Pd 103

I: Radioactive Seed Localized Breast Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Charles E. Cox, MD, FACS

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: April 2, 2004
• Study Start: November 1, 1999
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2006
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

US (1)