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

{ "Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors", "This study is looking at how well and how safely a special dye called Indocyanine Green (ICG) works during surgery for children and young adults up to age 20. The ICG dye is given into a vein to help surgeons find lymph nodes that might have cancer from solid tumors in the abdomen, specifically Wilms tumor or para-testicular rhabdomyosarcoma. The goal is to see if the dye helps surgeons successfully locate these lymph nodes and if there are any serious side effects from the dye. The study is currently unclear on its recruitment status and plans to enroll 25 participants.", "design": "This is an interventional study, meaning participants will receive a specific treatment (Indocyanine Green). It plans to enroll 25 participants.", "commitments": "During surgery, you will receive the Indocyanine Green dye. Pictures or a video of the procedure will be taken, and the removed lymph nodes will be examined after surgery.", "compensation": "Not stated in the trial record.", "follow_up": "You will be followed for up to 24 hours after surgery to check for any side effects from the dye.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05645523

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

Recruiting
EARLY_PHASE1Up to 20InterventionalDiagnostic
St. Jude Children's Research Hospital
~25 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Indocyanine Green

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful
Measured over During surgery (Intraoperatively)
+1 more outcome measured

Conditions

Solid Tumor

Explore related trials

RhabdomyosarcomaSolid NeoplasmWilms Tumor

Where it's being run

3 sites across 3 states
Illinois1
Pennsylvania1
Tennessee1

Study leadership

  • Andrew Davidoff, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Andrew Davidoff, MD
[email protected]
888-226-4343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Any patient under the age of 21 years with visceral pediatric solid tumor suspected to be Wilms tumor or para-testicular rhabdomyosarcoma requiring retroperitoneal lymph node dissection.

Exclusion

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.

What this trial measures

  • Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successfulDuring surgery (Intraoperatively)

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

  • Percentage of patients with grade 3 or higher adverse events related to ICG useFrom 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.