Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012168
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2001-03-03
Brief Title:
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1915 | None | None | None |
| NYU-9917 | None | None | None |