Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-05 @ 5:42 AM
Study NCT ID:
NCT02364960
Status:
TERMINATED
Last Update Posted:
2018-08-22
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
Sponsor:
TriHealth Inc.
Organization:
Study Overview
Official Title:
Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study site will join the TARGIT-US trial in lieu of this trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARGIT
Brief Summary:
The purpose of this study is to create a registry to evaluate the use of intra-operative radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery,
Detailed Description:
A registry trial has been designed and modeled after the original successful TARGIT protocol, to continue the use of IORT for a select population of women, and to follow outcomes with regards to local and regional control, toxicity and morbidity. Patients selected for breast conserving surgery, who are considered to have a low risk of local recurrence, are eligible for this registry trial once their informed consent is obtained. This single arm cohort study allows entry of patients who have been diagnosed with early stage breast cancer and whose clinical stage is suitable for treating conservatively (small tumor and no gross nodal involvement). Tumors should not be more than 3.5 cm in size.
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?: