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Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003186
First received: November 1, 1999
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Colorectal Cancer
Metastatic Cancer
Drug: isosulfan blue
Procedure: lymphangiography
Procedure: sentinel lymph node biopsy

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Dynamic In Vivo Lymphography and Sentinel Node Biopsy in Colorectal Cancer: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: April 1997
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003186

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Miguel A. Rodriguez-Bigas, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003186     History of Changes
Other Study ID Numbers: DS 96-57, RPCI-DS-96-57, NCI-G98-1371
Study First Received: November 1, 1999
Last Updated: February 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
adenocarcinoma of the colon
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014