Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
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.
Head and Neck Cancer
Drug: isosulfan blue
Genetic: polymerase chain reaction
Other: immunohistochemistry staining method
Procedure: radionuclide imaging
Procedure: sentinel lymph node biopsy
Radiation: technetium Tc 99m sulfur colloid
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer|
|Study Start Date:||May 1999|
|Primary Completion Date:||July 2003 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012168
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Moni A. Kuriakose, MD||New York University School of Medicine|