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Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00003186
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : February 5, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute

Brief Summary:

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 or disease Intervention/treatment
Colorectal Cancer Metastatic Cancer Drug: isosulfan blue Procedure: lymphangiography Procedure: sentinel lymph node biopsy

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.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Diagnostic
Official Title: Dynamic In Vivo Lymphography and Sentinel Node Biopsy in Colorectal Cancer: A Feasibility Study
Study Start Date : April 1997
Primary Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


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): NCT00003186


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

Publications:
ClinicalTrials.gov Identifier: NCT00003186     History of Changes
Other Study ID Numbers: DS 96-57
RPCI-DS-96-57
NCI-G98-1371
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes