Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003186
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Dynamic In Vivo Lymphography and Sentinel Node Biopsy in Colorectal Cancer A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2013-02
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 lymphography may improve the identification of patients with metastatic colorectal cancer
PURPOSE Clinical trial to study the effectiveness of lymphography in determining the presence or absence of metastatic colorectal cancer in patients
PURPOSE Clinical trial to study the effectiveness of lymphography in determining the presence or absence of metastatic colorectal cancer in patients
Detailed Description:
OBJECTIVES I Confirm that injection of isosulfan blue into the mucosa or serosa immediately adjacent to a colorectal cancer results in the lymphatic transport of that agent initially to a specific regional lymph node that can readily be identified on visual inspection dissected and histologically evaluated for the presence or absence of metastatic disease
OUTLINE All patients receive an injection of isosulfan blue into peritumor serosa upon intraoperative identification of the primary tumor prior to mesenteric mobilization If colonoscopy is otherwise indicated the injection may be delivered to the peritumor mucosa via colonoscopy during the case The mesentery adjacent to the injection is inspected and the lymphatic pattern and nodes demonstrated by the isosulfan blue are diagrammed and photographed The sentinel nodes are surgically dissected and evaluated If needed a second injection of isosulfan blue may be given Prior to mobilization of liver for resection of metastases isosulfan blue is injected subcapsularly around the metastatic lesion
PROJECTED ACCRUAL There will be 10 patients accrued into this study
OUTLINE All patients receive an injection of isosulfan blue into peritumor serosa upon intraoperative identification of the primary tumor prior to mesenteric mobilization If colonoscopy is otherwise indicated the injection may be delivered to the peritumor mucosa via colonoscopy during the case The mesentery adjacent to the injection is inspected and the lymphatic pattern and nodes demonstrated by the isosulfan blue are diagrammed and photographed The sentinel nodes are surgically dissected and evaluated If needed a second injection of isosulfan blue may be given Prior to mobilization of liver for resection of metastases isosulfan blue is injected subcapsularly around the metastatic lesion
PROJECTED ACCRUAL There will be 10 patients accrued into this study
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-G98-1371 | None | None | None |
| RPCI-DS-96-57 | None | None | None |