Lymphoscintigraphy to Detect Early Metastases in Patients... | NCT00012168

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

NCT00012168

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Mar 11, 2016Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Head and Neck Cancer

Interventions

isosulfan blue
polymerase chain reaction
immunohistochemistry staining method
lymphangiography
radionuclide imaging
sentinel lymph node biopsy
technetium Tc 99m sulfur colloid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1999

Primary Completion Date

Jul 2003Actual

Completion Date

Not provided

First Submitted Date

Mar 3, 2001

First Submission Date that Met QC Criteria

Jan 26, 2003

First Posted Date

Jan 27, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2016

Last Update Posted Date

Mar 11, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Conditions Module

Conditions

Head and Neck Cancer

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Moni A. Kuriakose, MD	NYU Langone Health	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
NYU School of Medicine's Kaplan Comprehensive Cancer Center		New York	New York	10016	United States

ID	Term
D006258	Head and Neck Neoplasms
D009959	Oropharyngeal Neoplasms
D009062	Mouth Neoplasms
D000077195	Squamous Cell Carcinoma of Head and Neck

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases
D010038	Otorhinolaryngologic Diseases
D009059	Mouth Diseases
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
C025484	iso-sulfan blue
D016133	Polymerase Chain Reaction
D007150	Immunohistochemistry
D021701	Sentinel Lymph Node Biopsy
D013671	Technetium Tc 99m Sulfur Colloid

Ancestor Terms

ID	Term
D021141	Nucleic Acid Amplification Techniques
D005821	Genetic Techniques
D008919	Investigative Techniques
D006651	Histocytochemistry
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006652	Histological Techniques
D007158	Immunologic Techniques
D001706	Biopsy
D003581	Cytodiagnosis
D013048	Specimen Handling
D003949	Diagnostic Techniques, Surgical
D013514	Surgical Procedures, Operative
D008197	Lymph Node Excision
D013457	Sulfur Compounds
D007287	Inorganic Chemicals
D017556	Technetium Compounds

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

ID	Type	Description	Link
NYU-9917
NCI-G01-1915