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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2026-12-31

Brief Summary

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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 Objectives

* 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.
* To determine the percentage of patients with grade 3 or higher adverse events related to ICG use.

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Detailed Description

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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.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Indocyanine green (ICG)

Participants will receive Indocyanine green intraoperatively.

Group Type EXPERIMENTAL

Indocyanine Green

Intervention Type DRUG

Given in to the vein (IV)

Interventions

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Indocyanine Green

Given in to the vein (IV)

Intervention Type DRUG

Other Intervention Names

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IC-GREEN™ ICG

Eligibility Criteria

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Inclusion Criteria

* 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 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.

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No