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Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00012168
First received: March 3, 2001
Last updated: November 8, 2012
Last verified: January 2004
History of Changes
  Purpose

RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to detect the spread of mouth and throat cancer to lymph nodes in the neck.

PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have mouth or throat cancer.


Condition Intervention
Head and Neck Cancer
 Drug: isosulfan blue
Genetic: polymerase chain reaction
Other: immunohistochemistry staining method
Procedure: lymphangiography
Procedure: radionuclide imaging
Procedure: sentinel lymph node biopsy
Radiation: technetium Tc 99m sulfur colloid

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Study Start Date: May 1999
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Evaluate the sensitivity of lymphoscintigraphy and isosulfan blue in localization of sentinel lymph nodes in patients with previously untreated squamous cell carcinoma of the oral cavity or oropharynx.
  • Determine evidence of micrometastases in histologically normal sentinel lymph nodes resected from these patients.
  • Assess the clinical significance of micrometastases in lymph nodes resected from these patients.

OUTLINE: Patients undergo preoperative lymphoscintigraphy utilizing technetium Tc 99m sulfur colloid followed by intraoperative injections of isosulfan blue at 3-4 locations into the primary tumor periphery. Once the afferent lymphatic channel and sentinel node have been identified, patients undergo cervical lymphadenectomy followed by resection of the primary tumor.

Resected primary tumor, radioactive lymph nodes, and blue-stained sentinel nodes are then subjected to molecular (polymerase chain reaction) and histocytochemical (immunohistochemistry for cytokeratin and micrometastases, light microscopy) analyses.

Patients are followed at 1, 3, 6, 12, 18, and 24 months.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary squamous cell carcinoma of the oral cavity or oropharynx

    • Stage 0-IVA (Any T, N0)
  • No low-risk tumors
  • Must require elective staging neck dissection and resection of primary tumor

PATIENT CHARACTERISTICS:

Age:

  • 18 to 70

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • No concurrent impaired mental status

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  • No prior surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012168

Locations
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Investigators
Study Chair: Moni A. Kuriakose, MD New York University School of Medicine
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00012168     History of Changes
Other Study ID Numbers: CDR0000068489, NYU-9917, NCI-G01-1915
Study First Received: March 3, 2001
Last Updated: November 8, 2012
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
stage 0 oropharyngeal cancer
stage 0 lip and oral cavity cancer
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
 stage IV squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms by Site
 Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013