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| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborator: |
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 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 |
| Study Start Date: | May 1999 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed primary squamous cell carcinoma of the oral cavity or oropharynx
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| 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 |
More Information
| 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: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Head and Neck Neoplasms Mouth Neoplasms Neoplasms by Site |
Neoplasms Mouth Diseases Stomatognathic Diseases |
