- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00012168
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer
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 Overview
Status
Conditions
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Moni A. Kuriakose, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage I squamous cell carcinoma of the lip and oral cavity
- stage II 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 0 oropharyngeal cancer
- stage 0 lip and oral cavity cancer
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068489
- NYU-9917
- NCI-G01-1915
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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