Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT02432118
Status:
WITHDRAWN
Last Update Posted:
2017-02-02
First Post:
2015-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
Status:
WITHDRAWN
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.
Detailed Description:
PRIMARY OBJECTIVES:
I. To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast.
SECONDARY OBJECTIVES:
I. To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system.
OUTLINE:
Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
I. To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast.
SECONDARY OBJECTIVES:
I. To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system.
OUTLINE:
Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-00630 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 348 | None | None | View | |
| BRS0053 | OTHER | Stanford University Hospitals and Clinics | View | |
| P30CA124435 | NIH | None | https://reporter.nih.gov/quic… | View |