Head and Neck NeoplasmsSLN MappingNCT02478138
Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging
A study testing Sentinel lymph node mapping, Indocyanine Green (ICG) and near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo) in people with Head and Neck Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Sentinel lymph node mapping, Indocyanine Green (ICG) and near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Sentinel lymph node mapping, Indocyanine Green (ICG), near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node mappingProcedure or surgery
Also called near-infrared (NIR) fluorescent dye indocyanine green
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)Drug
near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)Device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Sentinel lymph node mapping; Drug: Indocyanine Green (ICG); Device: near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan C Irish, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478138
- Sponsor's protocol ID
- 14-7441
- Acronym
- SLN Mapping
- Status last verified
- Apr 2024
- First submitted
- 1 Jun 2015
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging
- ClinicalTrials.gov ID
- NCT02478138
- Acronym / sponsor ID
- SLN Mapping / 14-7441
- Conditions
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical - therapeutic | Other | Procedure: Sentinel lymph node mapping, Drug: Indocyanine Green (ICG), Device: near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel lymph node mappingAlso: near-infrared (NIR) fluorescent dye indocyanine greenThirty (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. | Procedure or surgery | Surgical - therapeutic |
| Indocyanine Green (ICG) | Drug | Surgical - therapeutic |
| near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo) | Device | Surgical - therapeutic |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan C Irish, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel lymph node mapping, Indocyanine Green (ICG) and near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo) in people with Head and Neck Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICG imaging to identify lymph nodes metastases in head and neck cancer (time frame: During surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.