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Trial record 54 of 11741 for:    Oral Cancer

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 : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE June 1, 2015
First Posted Date  ICMJE June 23, 2015
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02478138 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging
Official Title  ICMJE Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Head and Neck Neoplasms
Intervention  ICMJE
  • 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)
Study Arms  ICMJE 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
Interventions:
  • Procedure: Sentinel lymph node mapping
  • Drug: Indocyanine Green (ICG)
  • Device: near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jonathan C Irish, MD 416-946-2149 jonathan.irish@uhn.ca
Contact: Nidal Muhanna, MD 647-993-0823 nidal.muhanna@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02478138
Other Study ID Numbers  ICMJE 14-7441
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan C Irish, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP