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


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Methylene Blue Oral

Methblue 65; Urolene Blue 




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

This study has been completed.

Sponsors and Collaborators: Kaplan Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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.

Condition Treatment or Intervention
lip and oral cavity cancer
Oropharyngeal Cancer
 Drug: isosulfan blue
 Drug: technetium Tc 99m sulfur colloid
 Procedure: diagnostic test
 Procedure: immunohistochemistry
 Procedure: lymphography
 Procedure: polymerase chain reaction
 Procedure: radionuclide imaging
 Procedure: sentinel node biopsy

MedlinePlus related topics:  Head and Neck Cancer;   Oral Cancer

Study Type: Interventional
Study Design: Diagnostic

Official Title: Pilot Study of Preoperative Lymphoscintigraphy Followed by Intraoperative Lymphatic Mapping for Sentinel Node Localization and Biopsy in Patients With Previously Untreated Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

Location Information


New York
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

Study chairs or principal investigators

Abraham Kuriakose, MD,  Study Chair,  Kaplan Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068489; NYU-9917; NCI-G01-1915
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  March 3, 2001
ClinicalTrials.gov Identifier:  NCT00012168
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 3, 2009



Page Updated: June 1, 2005
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