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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

New York University School of Medicine

ClinicalTrials.gov Identifier:

NCT00012168

First received: March 3, 2001

Last updated: November 8, 2012

Last verified: January 2004

History of Changes

Tracking Information

First Received Date ^ICMJE

March 3, 2001

Last Updated Date

November 8, 2012

Start Date ^ICMJE

May 1999

Primary Completion Date

July 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00012168 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Primary Purpose: Diagnostic

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

July 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00012168

Other Study ID Numbers ^ICMJE

CDR0000068489, NYU-9917, NCI-G01-1915

Has Data Monitoring Committee

Not Provided

Responsible Party

New York University School of Medicine

Study Sponsor ^ICMJE

New York University School of Medicine

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Moni A. Kuriakose, MD

New York University School of Medicine

Information Provided By

New York University School of Medicine

Verification Date

January 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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