Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder - Tabular View

Tracking Information

First Received Date ^ICMJE

June 20, 2007

Last Updated Date

September 18, 2009

Start Date ^ICMJE

February 1999

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety, as determined by the number of adverse events [ Designated as safety issue: Yes ]
Feasibility, in terms of the proportion of patients in whom a sentinel lymph node is identified [ Designated as safety issue: No ]
Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Safety, as determined by the number of adverse events
Feasability, in terms of the proportion of patients in whom a sentinel node is identified
Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved in the tumor

Change History

Complete list of historical versions of study NCT00489515 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison of sentinel lymph node results vs other nodes [ Designated as safety issue: No ]
Comparison of IHC analysis vs standard analysis of the sentinel lymph node [ Designated as safety issue: No ]
Value of intraoperative touch prep analysis of sentinel lymph nodes vs standard pathology [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Comparison of sentinel node results vs other nodes
Comparison of IHC analyses vs standard analyses
Value of intraoperative touch prep analysis of sentinal nodes vs standard pathology

Descriptive Information

Brief Title ^ICMJE

Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder

Official Title ^ICMJE

Visceral Lymphatic Mapping Project: A Pilot Study

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

Evaluate the safety and feasibility of visceral lymphatic mapping using isosulfan blue in patients with adenocarcinoma of the pancreas, colon, stomach, small bowel, or gallbladder.
Evaluate the ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes in the basin are involved with the tumor in these patients.

Secondary

Compare the results obtained from the sentinel lymph node (i.e., positive or negative for metastatic disease) with the results obtained from the other nodes in these patients.
Compare immunohistochemical analysis with standard analysis of the sentinel lymph nodes in these patients.
Evaluate the value of intraoperative touch prep analysis of sentinel lymph nodes in these patients.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Colorectal Cancer
Gallbladder Cancer
Gastric Cancer
Pancreatic Cancer
Small Intestine Cancer

Intervention ^ICMJE

Drug: isosulfan blue
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: conventional surgery
Procedure: lymphadenectomy
Procedure: lymphangiography
Procedure: sentinel lymph node biopsy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

125

Completion Date

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of adenocarcinoma of 1 of the following sites:
- Pancreas
- Stomach
- Colon
- Small bowel
- Gallbladder
Patients with highly suspicious pancreatic lesions without definitive tissue biopsy are eligible
No prior uncontrolled visceral malignancy

PATIENT CHARACTERISTICS:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No medical comorbidities that would preclude definitive resection
No known allergies to isosulfan blue

PRIOR CONCURRENT THERAPY:

Not specified

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00489515

Responsible Party

Study ID Numbers ^ICMJE

CDR0000550095, CCCWFU-99B98, CCCWFU-BG99-047

Study Sponsor ^ICMJE

Wake Forest University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Edward A. Levine, MD

Wake Forest University

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP