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

NCT ID: NCT02478138

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2024-01-08

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.

Detailed Description

Clinical systems for fluorescence imaging using ICG have recently been published with reported SLN identification rates of 94-100% in breast and colorectal cancers. The traditional radioisotope method enables navigation to the site of skin incision by measurement of radiation uptake, whereas the ICG fluorescence method can precisely identify the site of skin incision by tracing the lymphatic vessels across the skin and without radiation exposure. Systematic reviews have shown that the incidence of false negative SLN biopsy is high in head and neck applications. Therefore, the fluorescence SLN method, can potentially provide more precise information regarding which lymph nodes should be removed. As the ICG fluorescence technique can identify the basin that includes not only SLNs but also para-SLNs where the lymphatic vessels drain, the average number of lymph nodes removed also tends to increase. In preliminary studies, the ICG technique achieves a high identification rate comparable to that of the radioactive method. There has been to date, however, only limited studies of this technique in the area of oral cancer lymph node mapping. In our study we propose to evaluate the potential application of ICG in the mapping and detection of SLN in cancers of the head and neck in comparison with the radioactive agent method. We hypothesize that NIR-guided SLNB could present a new, safe and sensitive alternative or addition to the conventional SLN procedure.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Surgical - therapeutic

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

Group Type: OTHER

Sentinel lymph node mapping

Intervention Type: 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.

Indocyanine Green (ICG)

Intervention Type: DRUG

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

Intervention Type: DEVICE

Interventions

Sentinel lymph node mapping

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.

Intervention Type: PROCEDURE

Indocyanine Green (ICG)

Intervention Type: DRUG

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

Intervention Type: DEVICE

Other Intervention Names

near-infrared (NIR) fluorescent dye indocyanine green

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan C Irish, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

14-7441

Identifier Type: -

Identifier Source: org_study_id