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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: isosulfan blue|nan|
|Genetic: polymerase chain reaction|nan|
|Other: immunohistochemistry staining method|nan|
|Procedure: lymphangiography|nan|
|Procedure: radionuclide imaging|nan|
|Procedure: sentinel lymph node biopsy|nan|
|Radiation: technetium Tc 99m sulfur colloid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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