Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT00802932
Status:
COMPLETED
Last Update Posted:
2013-01-30
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Tx
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
Official Title:
Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Treatment
Status:
COMPLETED
Status Verified Date:
2013-01
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:
The purpose of this study is to test metallic markers in the breast tissue after breast conserving surgery and to observe the metallic markers' stability in the breast for use as tumor bed markers and positioning devices for radiation treatment.
Detailed Description:
In order to validate metallic marker placement and stability, patients will have the internal metallic markers placed at the time of their last breast surgery (either lumpectomy or re-excision for margins) by the surgeon and are permanent. They will undergo routine 3D CT-based treatment planning and will receive routine radiation treatment to the whole breast or partial breast as determined by the treating physician. Daily images of the breast will be obtained throughout treatment using the online portal imaging system. These images will be analyzed for the daily position of the metallic markers and compared across the entire course of treatment to determine the stability of metallic markers placement and to assess their efficacy as positioning devices for image guided radiation therapy.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 106406 | OTHER | USF IRB | View |