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

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ClinicalTrials.gov Identifier: NCT02478138
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Procedure: Sentinel lymph node mapping Drug: Indocyanine Green (ICG) Device: near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
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
Procedure: 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.
Other Name: near-infrared (NIR) fluorescent dye indocyanine green

Drug: Indocyanine Green (ICG)
Device: near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)



Primary Outcome Measures :
  1. ICG imaging to identify lymph nodes metastases in head and neck cancer [ Time Frame: During surgical procedure ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478138


Contacts
Contact: Jonathan C Irish, MD 416-946-2149 jonathan.irish@uhn.ca
Contact: Nidal Muhanna, MD 647-993-0823 nidal.muhanna@uhn.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Nidal Muhanna, MD    647-993-0823    nidal.muhanna@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Jonathan C Irish, MD University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02478138     History of Changes
Other Study ID Numbers: 14-7441
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases