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Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tissue Loss Rates for Each Arm

Outcome Description:

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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Charles E. Cox, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-12114

NCT ID:

NCT00006031

Start Date:

November 1999

Completion Date:

July 2006

Related Keywords:

  • Breast Cancer
  • biopsy
  • radioactive seed
  • nonpalpable lesions
  • Breast Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612