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Comparison of Two Types of Biopsy in Patients With Breast Lesions

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ClinicalTrials.gov Identifier: NCT00006031
Recruitment Status : Completed
First Posted : April 2, 2004
Last Update Posted : September 26, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Needle localized breast biopsy with specimen x-ray Procedure: Low dose radioactive seed followed by surgery and mammogram Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
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
Study Start Date : November 1999
Actual Primary Completion Date : July 2001
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Number of Participants with Adverse Events for Each Group [ Time Frame: 18 months ]
    Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


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

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 Posted: April 2, 2004    Key Record Dates
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