Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT01960803
Status:
WITHDRAWN
Last Update Posted:
2024-10-04
First Post:
2013-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IOERT is no longer an experimental treatment and was now offered as SOC to patients experiencing IBC. As this therapy is being offered to them regardless of study participation at numerous institutions across the country.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.
Detailed Description:
Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.
Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.
Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.
Study Oversight
Has Oversight DMC:
False
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?: