Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005640
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2000-05-02
Brief Title:
Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2012-09
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 Diagnostic procedures such as lymph node mapping and biopsy may improve the ability to detect the extent of colorectal cancer
PURPOSE Diagnostic trial to study the feasibility of lymph node mapping and sentinel lymph node biopsy in patients who have stage I stage II or stage III colorectal cancer
PURPOSE Diagnostic trial to study the feasibility of lymph node mapping and sentinel lymph node biopsy in patients who have stage I stage II or stage III colorectal cancer
Detailed Description:
OBJECTIVES I Determine the feasibility of lymphatic mapping and sentinel lymph node biopsy in patients with stage I II or III colorectal cancer II Evaluate technetium Tc 99m sulfur colloid as a mapping agent in this patient population III Identify patients with histologically negative nodes but have positive nodes on further detailed examination
OUTLINE Patients undergo preoperative endoscopy with injection of technetium Tc 99m sulfur colloid around tumor followed by celiotomy and intraabdominal exploration At 30 minutes following injection patients undergo lymphatic mapping with a gamma probe and biopsy of the sentinel lymph nodes Following biopsy and mapping patients undergo resection of primary tumor Patients are followed postoperatively every 4-6 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 2 years
OUTLINE Patients undergo preoperative endoscopy with injection of technetium Tc 99m sulfur colloid around tumor followed by celiotomy and intraabdominal exploration At 30 minutes following injection patients undergo lymphatic mapping with a gamma probe and biopsy of the sentinel lymph nodes Following biopsy and mapping patients undergo resection of primary tumor Patients are followed postoperatively every 4-6 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1780 | OTHER | NCI | None |