- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02478138
Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging (SLN Mapping)
April 11, 2024 updated by: University Health Network, Toronto
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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During surgical procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jonathan C Irish, MD, University Health Network, Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
January 8, 2024
Study Completion (Actual)
January 8, 2024
Study Registration Dates
First Submitted
June 1, 2015
First Submitted That Met QC Criteria
June 22, 2015
First Posted (Estimated)
June 23, 2015
Study Record Updates
Last Update Posted (Estimated)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 11, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-7441
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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