Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006031
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2000-07-05
Brief Title:
Comparison of Two Types of Biopsy in Patients With Breast Lesions
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1808 | OTHER | NCI | None |