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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00005640

Enrollment

Registered

2004-05-26

Start date

1999-06-30

Completion date

2002-02-28

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer

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.

Interventions

PROCEDUREPreoperative Endoscopy

RADIATIONTechnetium Tc 99m Sulfur Colloid

PROCEDUREGamma Probe

PROCEDUREBiopsy of Sentinel Lymph Nodes

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: Preoperative diagnosis of stage I, II, or III colorectal cancer No more than 90 days since diagnosis No tumor involving adjacent structures (T4 lesion) No clinical or radiological evidence of stage IV disease No total excision of primary tumor at diagnosis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No severe decompensated liver disease, including cirrhosis Renal: Not specified Other: No known primary or secondary immunodeficiencies No other medical conditions or evidence of infection that would preclude study Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior colonic, aortic, or retroperitoneal surgery

Design outcomes

Primary

Measure	Time frame	Description
Number of Procedures Resulting in Improved Detection	18 months	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026