Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging

NCT02478138 | Completed

• 1 other identifier: 14-7441
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical lymph node involvement, in head and cancer neck patients, is one of the most important prognostic factors. Currently patients undergo neck dissection removing some or all nodes and neck involvement is retrospectively determined. Sentinel lymph node (SLN) identification and biopsy has become clinical practise in other areas including breast, skin, and gastric cancer. The gold standard for detecting metastatic lymph nodes is pathological analysis, but the lack of an accurate or clinically accepted way to identify sentinel lymph nodes in the cervical region has motivated the usage of indocyanine green (ICG) and near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo). A prospective clinical trial using a commercially available NIR system and ICG injection around the tumour site will evaluate the ability to detect and biopsy sentinel lymph nodes in head and neck cancer patients.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• ICG imaging to identify lymph nodes metastases in head and neck cancer

  The aim of this proposal is to evaluate the potential application of Indocyanine Green (ICG) in the mapping and detection of sentinel lymph nodes (SLN) in cancers of the head and neck.

  During surgical procedure

Study Arms (1)

Surgical - therapeutic

OTHER

patients will be enrolled under informed consent based upon their medical diagnosis, planned surgical procedures, and suitability for the procedure. During the study, patients will receive injections of ICG and will be imaged using a commercial NIR imaging system

Procedure: Sentinel lymph node mapping; Drug: Indocyanine Green (ICG); Device: near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)

Interventions

Sentinel lymph node mapping PROCEDURE

Thirty (30) patients will be enrolled under informed consent based upon their medical diagnosis, planned surgical procedures, and suitability for the procedure. During the study, patients will receive injections of ICG and will be imaged using a commercial NIR imaging system (Pinpoint, Novadaq, Waterloo ON). After the study, patients will continue with their planned management.

Also known as: near-infrared (NIR) fluorescent dye indocyanine green

Surgical - therapeutic

Indocyanine Green (ICG) DRUG

Surgical - therapeutic

near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo) DEVICE

Surgical - therapeutic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will include patients with tumors or other masses in the following sites: oral cavity, oropharynx, nasal cavity, sinuses, nasopharynx, parapharyngeal space, parotid salivary glands, head and neck skin and skull base.
• N0 neck status
• The patients should have a complete and detailed medical record.
• Subjects must be at least 18 years of age.
• Subjects must sign and be given a copy of the written Informed Consent Form.

You may not qualify if:

• Patients who are not able to consent by themselves or grasp the implication of the study.
• Subjects participating in any other clinical trial during the time of this clinical investigation and that may have an impact on this evaluation.
• Pregnant or potentially pregnant woman
• Lactation.
• Iodine, shellfish, cough mixture, betadine or ICG allergy

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Indocyanine Green; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jonathan C Irish, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 23, 2015
• Study Start: May 1, 2015
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CA (1)