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Comparison of Two Types of Biopsy in Patients With Breast Lesions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006031
First Posted: April 2, 2004
Last Update Posted: September 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
  Purpose

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.


Condition Intervention
Breast Cancer Procedure: Needle localized breast biopsy with specimen x-ray Procedure: Low dose radioactive seed followed by surgery and mammogram

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Tissue Loss Rates for Each Arm [ Time Frame: 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 [ Time Frame: 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:
  • Number of Participants with Adverse Events for Each Group [ Time Frame: 18 months ]
    Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.


Enrollment: 117
Study Start Date: November 1999
Study Completion Date: July 2006
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I: Radioactive Seed Localized Breast Biopsy
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
either iodine I 125 or palladium Pd 103
Active Comparator: Arm II: Needle Localized Breast Biopsy
Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.
Procedure: Needle localized breast biopsy with specimen x-ray

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006031


Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Charles E. Cox, MD, FACS H. Lee Moffitt Cancer Center and Research Institute
  More Information

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00006031     History of Changes
Other Study ID Numbers: MCC-12114
NCI-G00-1808 ( Other Identifier: NCI )
First Submitted: July 5, 2000
First Posted: April 2, 2004
Last Update Posted: September 26, 2012
Last Verified: September 2012

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
biopsy
radioactive seed
nonpalpable lesions