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

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ClinicalTrials.gov Identifier: NCT00005640
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : September 25, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.


Condition or disease Intervention/treatment
Colorectal Cancer Procedure: Preoperative Endoscopy Radiation: Technetium Tc 99m Sulfur Colloid Procedure: Gamma Probe Procedure: Biopsy of Sentinel Lymph Nodes

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Lymphatic Mapping and Sentinel Lymph Node Biopsy in the Treatment of Colorectal Cancer: A Feasibility Study
Study Start Date : June 1999
Primary Completion Date : February 2002
Study Completion Date : February 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mapping and Biopsy
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.
Procedure: Preoperative Endoscopy Radiation: Technetium Tc 99m Sulfur Colloid Procedure: Gamma Probe Procedure: Biopsy of Sentinel Lymph Nodes



Primary Outcome Measures :
  1. Number of Procedures Resulting in Improved Detection [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005640


Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Timothy J. Yeatman, M.D. H. Lee Moffitt Cancer Center and Research Institute

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00005640     History of Changes
Other Study ID Numbers: MCC-11785
NCI-G00-1780 ( Other Identifier: NCI )
First Posted: May 26, 2004    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Technetium Tc 99m Sulfur Colloid
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action