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Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05645523
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
34
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to find out the usefulness and safety of a dye called Indocyanine Green (ICG for short). This dye will be used to help the surgeon find lymph nodes draining solid tumors inside the abdomen that need to be removed. This may also help the surgeon to find if the cancer has moved to other lymph nodes outside of the known area.

Primary Objective

  • To determine the percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful at the time of retroperitoneal lymph node dissection for staging of visceral solid tumors. Also, to determine the percentage of patients with grade 3 or more adverse events.
Condition or Disease Intervention/Treatment Phase
  • Drug: Indocyanine Green
 Early Phase 1

Detailed Description

During surgery, participants will be given the dye to help the doctor see the lymph nodes to be removed. Pictures or a video of the procedure will be done. The number of lymph nodes removed will be recorded. After surgery, the lymph nodes will be examined.

Participants will be followed for up to 24 hours after surgery to determine if there were any side effects from the dye.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Feasibility and Safety of Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Indocyanine green (ICG)

Participants will receive Indocyanine green intraoperatively.

Drug: Indocyanine Green
Given in to the vein (IV)
Other Names:
  • IC-GREEN™
  • ICG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful [During surgery (Intraoperatively)]

      The estimated percentage of ICG identification and its confidence interval (CI) based on the Pearson-Klopper method exact method will be calculated.

    2. Percentage of patients with grade 3 or more adverse events [From the time of ICG administration to 24 hours after surgery (post-surgery)]

      Adverse Events will be captured from the time of ICG administration to 24 hours post-surgery. Adverse Events will be graded by this scale: the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Any patient under the age of 21 years with visceral pediatric solid tumor requiring retroperitoneal lymph node dissection.
    Exclusion Criteria:

    • Subjects with a history of iodide allergies.

    • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

    • Pregnant female.

    • Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital

    Investigators

    • Principal Investigator: Hafeez Abdelhafeez, MD, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05645523
    Other Study ID Numbers:
    • VISCERALx
    • NCI-2022-10202
    First Posted:
    Dec 9, 2022
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by St. Jude Children's Research Hospital
    Indocyanine Green
    Sentinel Lymph Node Mapping
    Pediatric
    Young Adult
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jan 12, 2023