Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | May 1999 |
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.
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.
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.
- 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.
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
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