Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020852
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2001-07-11
Brief Title:
Cryosurgery in Treating Women With Breast Lesions
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation
Status:
COMPLETED
Status Verified Date:
2004-05
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 Cryosurgery kills cancer cells by freezing them Cryosurgery followed by lumpectomy or mastectomy may be an effective treatment for breast lesions
PURPOSE Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions
PURPOSE Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions
Detailed Description:
OBJECTIVES
Determine the feasibility of temperature-monitored ultrasound-guided cryosurgery in women with highly suspicious breast lesions
Determine the safety of this procedure in these patients
OUTLINE This is a multicenter study
Patients undergo cryoablation of up to two breast lesions Within 3-21 days patients undergo lumpectomy or mastectomy
Patients are followed at 1 4 8 and 12 weeks after lumpectomy or mastectomy
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this study
Determine the feasibility of temperature-monitored ultrasound-guided cryosurgery in women with highly suspicious breast lesions
Determine the safety of this procedure in these patients
OUTLINE This is a multicenter study
Patients undergo cryoablation of up to two breast lesions Within 3-21 days patients undergo lumpectomy or mastectomy
Patients are followed at 1 4 8 and 12 weeks after lumpectomy or mastectomy
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1964 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068724 | REGISTRY | None | None |