NCT00012168

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

4.2 years

First QC Date

March 3, 2001

Last Update Submit

March 10, 2016

Conditions

Head and Neck Cancer

Keywords

stage 0 oropharyngeal cancerstage 0 lip and oral cavity cancerstage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynx

Interventions

isosulfan blueDRUG
polymerase chain reactionGENETIC
immunohistochemistry staining methodOTHER
lymphangiographyPROCEDURE
radionuclide imagingPROCEDURE
sentinel lymph node biopsyPROCEDURE
technetium Tc 99m sulfur colloidRADIATION

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsOropharyngeal NeoplasmsMouth NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

iso-sulfan bluePolymerase Chain ReactionImmunohistochemistrySentinel Lymph Node BiopsyTechnetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic TechniquesBiopsyCytodiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionSulfur CompoundsInorganic ChemicalsTechnetium Compounds

Study Officials

  • Moni A. Kuriakose, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2001

First Posted

January 27, 2003

Study Start

May 1, 1999

Primary Completion

July 1, 2003

Last Updated

March 11, 2016

Record last verified: 2016-03

Locations

US(1)