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Fluorescence Imaging in Sentinel Lymph Node Biopsy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT03297957
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no system has been studied specifically for head and neck sentinel lymph node biopsies using a hands free goggle system that can visualize white light (normal surgical visualization) and nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of time required to perform the SLNB procedure.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Cancer of the Head and Neck Drug: IC-GREEN Device: Hands-free goggle system Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Fluorescence Imaging in Sentinel Lymph Node Biopsy for Head and Neck Cancer
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Fluorescence Imaging
  • The patient will then be taken to the operating room, without deviating from normal operating procedures for this surgical procedure. Prior to starting the operation, the patient will undergo injection of ICG around the tumor per standard techniques while in the operating room
  • Patients will then undergo the standard SLN biopsy procedure.
  • After gamma probe and methylene blue identification of the SLN as per standard of care, the surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Lymph nodes that are fluorescent from ICG detected with the goggles will also be removed if the node identified in the dissected nodal basin. All three visualizations will be performed prior to removal and the nodes will then be sent for pathologic confirmation of node positivity or negativity.
Drug: IC-GREEN
-Injection of ICG around the tumor per standard techniques will in the operating room and 0.5-2.5 mL of 500 micromolar ICG will be injected peri-tumorly into the subcutaneous tissue of the surrounding skin.
Other Names:
  • Indocyanine green for injection
  • ICG

Device: Hands-free goggle system
-Manufactured at Washington University




Primary Outcome Measures :
  1. Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure [ Time Frame: Up to 1 week after surgery ]
    -Feasibility will be assessed in terms of percentage of patients enrolled for whom peri-tumoral injection with ICG is performed successfully

  2. Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure [ Time Frame: Up to 1 week after surgery ]
    -Feasibility will be assessed in terms of percentage patients whom the sentinel and superficial lymph nodes will be detected from the hands free goggle device

  3. Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure [ Time Frame: Up to 1 week after surgery ]
    -Feasibility will be assessed in terms of percentage of total lesions identified from the new technique are truly positive as confirmed by biopsy

  4. Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure [ Time Frame: Up to 1 week after surgery ]
    -Feasibility will be assessed in terms of the the percentage of total positive SNLs being missed from the new device


Secondary Outcome Measures :
  1. Determine if there is contrast between SLN and surrounding tissues using the novel fluorescence imaging device [ Time Frame: Up to 1 week after surgery ]


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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:

  • Adults aged 18 years or older will be considered eligible.
  • Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma, that are candidates for sentinel lymph node biopsy.

    *Newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy.

  • Not pregnant or breast feeding.
  • Able to understand and willing to sign an IRB-approved written informed consent document.
  • Able to understand written or spoken English.

Exclusion Criteria:

  • History of allergy to iodide drugs or shellfish (iodine allergy)
  • Pregnant or breast feeding
  • Do not fit age criteria
  • Prisoners
  • Unable to provide written consent
  • Contraindications for surgery

    *Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the head and neck, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

  • Receiving any other investigational agents

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): NCT03297957


Contacts
Contact: Ryan S Jackson, M.D. 314-362-0365 jackson.ryan@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ryan S Jackson, M.D.    314-362-0365    jackson.ryan@wustl.edu   
Principal Investigator: Ryan S Jackson, M.D.         
Sub-Investigator: Samuel Achilefu, B.S., M.S., Ph.D.         
Sub-Investigator: Jason Rich, M.D.         
Sub-Investigator: Lemoyne Habimana-Griffen, B.S.         
Sub-Investigator: Suman Mondal, M.S.         
Sub-Investigator: Avik Som, B.S.         
Sub-Investigator: Sara Kukuljan, R.N.         
Sub-Investigator: Dorina Kallogjeri, M.D., MPH         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Study Chair: Ryan S Jackson, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03297957     History of Changes
Other Study ID Numbers: 201708068
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms