Expired Study
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New York, New York 10016


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000068489


NCT ID:

NCT00012168


Secondary ID:

NYU-9917


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York University School of Medicine


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Diagnostic


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Moni A. Kuriakose, MD
Study Chair
New York University School of Medicine

Study Dates

Start Date:May 1999
Primary Completion Date:July 2003
Primary Completion Type:Actual
Verification Date:March 2016
Last Changed Date:March 10, 2016
First Received Date:March 3, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York University School of Medicine
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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