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

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ClinicalTrials.gov Identifier: NCT00012168
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE March 3, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date March 11, 2016
Study Start Date  ICMJE May 1999
Actual 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
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 Arms  ICMJE 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
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00012168
Other Study ID Numbers  ICMJE CDR0000068489
NYU-9917
NCI-G01-1915
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Moni A. Kuriakose, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date March 2016

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