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| Sponsor: | Wake Forest University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00489515 |
Purpose
RATIONALE: Diagnostic procedures, such as visceral lymphatic mapping using isosulfan blue, may help find cancer of the pancreas, colon, stomach, small intestine, or gallbladder and find out how far the disease has spread.
PURPOSE: This clinical trial is studying the side effects and how well visceral lymphatic mapping using isosulfan blue works in patients with cancer of the pancreas, colon, stomach, small intestine, or gallbladder.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer Gallbladder Cancer Gastric Cancer Pancreatic Cancer Small Intestine Cancer |
Drug: isosulfan blue Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: conventional surgery Procedure: lymphadenectomy Procedure: lymphangiography Procedure: sentinel lymph node biopsy |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Diagnostic |
| Official Title: | Visceral Lymphatic Mapping Project: A Pilot Study |
| Estimated Enrollment: | 125 |
| Study Start Date: | February 1999 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
During surgical resection of the primary tumor, patients receive isosulfan blue subcutaneously 5 minutes before undergoing sentinel lymph node identification/excision and radical lymphadenectomy. Tissue samples are analyzed by IHC for cytokeratins and CEA.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of adenocarcinoma of 1 of the following sites:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Study Chair: | Edward A. Levine, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
| ClinicalTrials.gov Identifier: | NCT00489515 History of Changes |
| Other Study ID Numbers: | CDR0000550095, CCCWFU-99B98, CCCWFU-BG99-047 |
| Study First Received: | June 20, 2007 |
| Last Updated: | September 18, 2009 |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the gallbladder stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer |
stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer localized gallbladder cancer small intestine adenocarcinoma adenocarcinoma of the colon adenocarcinoma of the pancreas adenocarcinoma of the stomach |
|
Colorectal Neoplasms Stomach Neoplasms Pancreatic Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Gallbladder Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Duodenal Diseases Ileal Diseases Jejunal Diseases Biliary Tract Neoplasms Biliary Tract Diseases Gallbladder Diseases |