Spots Global Cancer Trial Database for Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer

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Trial Identification

Brief Title: Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer

Official Title: Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer: A Feasibility Study

Study ID: NCT00005640

Conditions

Colorectal Cancer

Interventions

Preoperative Endoscopy

Technetium Tc 99m Sulfur Colloid

Gamma Probe

Biopsy of Sentinel Lymph Nodes

Study Description

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.

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 node(s). 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.