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

NYU Langone Health

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Genetic: polymerase chain reaction; Procedure: sentinel lymph node biopsy; Radiation: technetium Tc 99m sulfur colloid; Procedure: radionuclide imaging; Procedure: lymphangiography; Drug: isosulfan blue; Other: immunohistochemistry staining method

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00012168

NYU-9917

NCI-G01-1915

CDR0000068489

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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