Expired Study
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New York, New York 10016


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.


Study summary:

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.


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


NCT ID:

NCT00012168


Primary Contact:

Study Chair
Moni A. Kuriakose, MD
New York University School of Medicine


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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