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

This study has been completed.

Sponsors and Collaborators: New York University School of Medicine
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00012168
  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
Drug: technetium Tc 99m sulfur colloid
Procedure: immunohistochemistry staining method
Procedure: lymphangiography
Procedure: polymerase chain reaction
Procedure: radionuclide imaging
Procedure: sentinel lymph node biopsy

MedlinePlus related topics:   Cancer    Head and Neck Cancer    Nuclear Scans   

Drug Information available for:   Iso-sulfan blue   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   May 1999

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


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

Study ID Numbers:   CDR0000068489, NYU-9917, NCI-G01-1915
First Received:   March 3, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00012168
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Epidermoid carcinoma
Oral cancer
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasm Metastasis
Carcinoma, Squamous Cell
Lip and oral cavity cancer
Mouth Neoplasms
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008




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