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Clinical Trial: Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
This study has been completed.
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 | Treatment or Intervention |
|---|---|
| lip and oral cavity cancer Oropharyngeal Cancer | Drug: isosulfan blue Drug: technetium Tc 99m sulfur colloid Procedure: diagnostic test Procedure: immunohistochemistry Procedure: lymphography Procedure: polymerase chain reaction Procedure: radionuclide imaging Procedure: sentinel node biopsy |
MedlinePlus related topics: Head and Neck Cancer; Oral Cancer
Study Type: Interventional
Study Design: Diagnostic
Official Title: Pilot Study of Preoperative Lymphoscintigraphy Followed by Intraoperative Lymphatic Mapping for Sentinel Node Localization and Biopsy in Patients With Previously Untreated Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
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.
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for Study: Both
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
Location Information
New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, 10016, United States
Abraham Kuriakose, MD, Study Chair, Kaplan Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: February 2004
Last Updated: October 13, 2004
Record first received: March 3, 2001
ClinicalTrials.gov Identifier: NCT00012168
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Group A Streptococcal Infections (Cleveland Clinic)
- Strep throat (Google Health)

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