Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer

Overview

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.

Full Title of Study: “Dynamic In Vivo Lymphography and Sentinel Node Biopsy in Colorectal Cancer: A Feasibility Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Diagnostic
  • Study Primary Completion Date: March 2005

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 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.

PROJECTED ACCRUAL: There will be 10 patients accrued into this study.

Interventions

  • Drug: isosulfan blue
  • Procedure: lymphangiography
  • Procedure: sentinel lymph node biopsy

Participating in This Clinical Trial

DISEASE CHARACTERISTICS: Patients must be undergoing surgical resection of a colorectal primary adenocarcinoma Metastatic colorectal cancer to liver (hepatic metastases) allowed

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

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Roswell Park Cancer Institute
  • Collaborator
    • National Cancer Institute (NCI)
  • Overall Official(s)
    • Miguel A. Rodriguez-Bigas, MD, Study Chair, M.D. Anderson Cancer Center

Citations Reporting on Results

Kane JM 3rd, Kahlenberg MS, Rodriguez-Bigas MA, Gibbs JF, Petrelli NJ. Intraoperative hepatic lymphatic mapping in patients with liver metastases from colorectal carcinoma. Am Surg. 2002 Sep;68(9):745-50.

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