Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Completed	18-75	NCI	RPCI-DS-96-57 NCI-G98-1371, NCT00003186

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.

Entry Criteria

Disease Characteristics:

Patients must be undergoing surgical resection of a colorectal primary
adenocarcinoma

Metastatic colorectal cancer to liver (hepatic metastases) allowed

Prior/Concurrent Therapy:

See Disease Characteristics

Patient Characteristics:

Age:
 18 to 75

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No known or suspected allergy to isosulfan blue 
 Not pregnant

Expected Enrollment

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 node(s) 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.

Kane JM 3rd, Kahlenberg MS, Rodriguez-Bigas MA, et al.: Intraoperative hepatic lymphatic mapping in patients with liver metastases from colorectal carcinoma. Am Surg 68 (9): 745-50, 2002.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Miguel Rodriguez-Bigas, MD, Protocol chair		Ph: 713-745-4955; 800-392-1611 Email: mrodbig@mdanderson.org

Registry Information
Official Title		Dynamic In Vivo Lymphography and Sentinel Node Biopsy in Colorectal Cancer: A Feasibility Study
Trial Start Date		1997-04-15
Registered in ClinicalTrials.gov		NCT00003186
Date Submitted to PDQ		1998-01-14
Information Last Verified		2005-03-02
NCI Grant/Contract Number		P30-CA16056