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Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03532581
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John Phay, MD, Ohio State University Comprehensive Cancer Center

Brief Summary:
This phase I trial studies how well indocyanine green lymphangiography works in identifying thoracic duct during neck surgery. Diagnostic procedures, such as near infrared fluorescence imaging with indocyanine green may help recognize and prevent injury to thoracic duct during neck surgery.

Condition or disease Intervention/treatment Phase
Neck Dissection Radical Lymph Node Dissection Other: Indocyanine Green Solution Procedure: Lymphangiography Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Feasibility and optimization of thoracic duct identification using indocyanine green (ICG) lymphangiography.

II. To explore specifically how identifying the thoracic duct (TD) will prevent injury intra-operatively.

III. To understand if a TD injury can be recognized by leakage of fluorescent chyle into the operating field.

OUTLINE:

Participants receive indocyanine green solution subcutaneously (SC) and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.

After completion of study treatment, participants are followed up for up to 1 year.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Novel Surgical Technique: Indocyanine Green Lymphangiography for Identification of the Thoracic Duct During Neck Dissection
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (ICG lymphangiography)
Participants receive indocyanine green solution SC and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.
Other: Indocyanine Green Solution
Given Subcutaneous injection
Other Names:
  • IC-GREEN
  • ICG Solution

Procedure: Lymphangiography
Undergo lymphangiography
Other Name: Lymphography




Primary Outcome Measures :
  1. Identify thoracic duct (TD) using indocyanine green (ICG) [ Time Frame: Up to 1 year ]
    We will determine in how many patients the thoracic duct is identified by white light visualization and by ICG fluorescence. The collected data will be primarily qualitative as determined by the surgeon.

  2. Prevent injury to the TD [ Time Frame: Up to 1 year ]
    Percentage of patients with TD injury will be calculated and compared to contemporary rates of injury.

  3. Recognize injury intra-operatively [ Time Frame: Up to 1 year ]
    Will be mostly qualitative data collection on how the injury was identified and in what percent.



Information from the National Library of Medicine

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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:

  • Healthy adult patients who are undergoing LEFT modified radical or selective (including zone IV) lymph node dissection for any indication; this includes patients who have had prior neck surgery

Exclusion Criteria:

  • Children, minors, pregnant women, women who are breast feeding, institutionalized patients
  • Known prior allergic reaction to ICG or allergy to iodine
  • Patients with excessively high anesthesia risks who cannot tolerate the extra time under general anesthesia needed to perform this study; the surgeon and anesthesiologist will determine this pre-operatively

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): NCT03532581


Contacts
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Contact: Ohio State Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: John Phay    614-293-7171    John.Phay@osumc.edu   
Principal Investigator: John Phay         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John Phay, MD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: John Phay, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03532581    
Other Study ID Numbers: OSU-17368
NCI-2018-00390 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharmaceutical Solutions