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Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination Clinical research trials and Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination. Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination clinical trial. Participants frequently obtain the most expert healthcare available for their Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination



Comparison of Two Types of Biopsy in Patients With Breast Lesions That Cannot Be Felt Upon Examination

For Condition: Breast Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: 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.
Details: 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. PROTOCOL 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. PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CharlesCox,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612-9497
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068044;  NCI-G00-1808,MCC-IRB-5499,MCC-12114
Study Start Date: June 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006031

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