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

Head and Neck Cancer Clinical Trial

Official title:

Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012168
• Other study ID #: CDR0000068489
• Secondary ID: NYU-9917NCI-G01-
• Status: Completed
• Phase: N/A
• First received: March 3, 2001
• Last updated: March 10, 2016
• Start date: May 1999

Study information

• Verified date: March 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• isosulfan blue

Genetic:
• polymerase chain reaction

Other:
• immunohistochemistry staining method

Procedure:
• lymphangiography

• radionuclide imaging

• sentinel lymph node biopsy

Radiation:
• technetium Tc 99m sulfur colloid

Locations

Country	Name	City	State
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,