|
||||||||||||||||||||||
|
|
Diagnostic Study of Isosulfan Blue for Dynamic In Vivo Lymphography and Sentinel Node Biopsy in Patients With Colorectal Cancer (Summary Last Modified 04/2001)
Alternate Title Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
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.Published Results 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 Lead Organizations Roswell Park Cancer Institute
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |