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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
isosulfan blue
polymerase chain reaction
immunohistochemistry staining method
lymphangiography
radionuclide imaging
sentinel lymph node biopsy
technetium Tc 99m sulfur colloid
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 3, 2001
Last Updated
March 10, 2016
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00012168
Brief Title
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
Official Title
Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
isosulfan blue
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Procedure
Intervention Name(s)
lymphangiography
Intervention Type
Procedure
Intervention Name(s)
radionuclide imaging
Intervention Type
Procedure
Intervention Name(s)
sentinel lymph node biopsy
Intervention Type
Radiation
Intervention Name(s)
technetium Tc 99m sulfur colloid

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moni A. Kuriakose, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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