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Technetium Tc 99m Sulfur Colloid

Radiopharmaceuticals

Cola

Lymph node mapping and sentinel lymph node biopsy. 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.

Preoperative Endoscopy

Gamma Probe

Biopsy of Sentinel Lymph Nodes

Timothy J. Yeatman, M.D.

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.

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.

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

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

Determine the feasibility of lymphatic mapping and sentinel lymph node biopsy in patients with stage I, II, or III colorectal cancer. Evaluate technetium Tc 99m sulfur colloid as a mapping agent in this patient population. Identify patients with histologically negative nodes but have positive nodes on further detailed examination.

National Cancer Institute (NCI)

H. Lee Moffitt Cancer Center and Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer	NCT00005640	Colorectal Canc...	Preoperative En... Technetium Tc 9... Gamma Probe Biopsy of Senti...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer	NCT00005640	Colorectal Canc...	Preoperative En... Technetium Tc 9... Gamma Probe Biopsy of Senti...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer	NCT00005640	Colorectal Canc...	Preoperative En... Technetium Tc 9... Gamma Probe Biopsy of Senti...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for preoperative endoscopy