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Dynamic In Vivo Lymphography and Sentinel Node Biopsy in Colorectal Cancer: A Feasibility Study


N/A
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

Dynamic In Vivo Lymphography and Sentinel Node Biopsy in Colorectal Cancer: A Feasibility Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Miguel A. Rodriguez-Bigas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

DS 96-57

NCT ID:

NCT00003186

Start Date:

April 1997

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • 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
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263