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

May 25, 2017 updated by: Wake Forest University Health Sciences

Visceral Lymphatic Mapping Project: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157-1096
    - Wake Forest University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with gastrointestinal cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
patients with gastrointestinal cancer scheduled for surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, as determined by the number of adverse events resulting from procedure Time Frame: 1 week	Safety will be assessed by documenting the number of adverse clinical events resulting from the procedure	1 week
Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor Time Frame: 1 week		1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Edward A. Levine, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria