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Indocyanine Green (ICG) Guided Tumor Resection

NCT04084067 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-04-30

No results posted yet for this study

Summary

This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and/or metastatic deposits is critical for achieving a cure. An optimal intra-operative tool to help visualize tumor and its margins would be of benefit. ICG real-time fluorescence imaging is a technique being used increasingly in adults for this purpose. We propose to use it during surgery for pediatric malignancies. All patients with tumors that require localization for resection or biopsy of the tumor and/or metastatic lesions will be eligible.

Primary Objective

To assess the feasibility of Indocyanine Green (ICG)-mediated near-infrared (NIR) imagery to identify neoplastic disease during the conduct of surgery to resect neoplastic lesions in children and adolescents. NIR imaging will be done at the start of surgery to assess NIR-positivity of the lesion(s) and at the end of surgery to assess completeness of resection. Separate assessments will be made for the following different histologic categories:

1. Osteosarcoma
2. Neuroblastoma
3. Metastatic pulmonary deposits - closed to accrual

Exploratory Objectives

1. To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated.
2. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback.
3. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging.
4. Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection.

Separate assessments will be made for the following different histologic categories based on their actual enrollment; this includes but is not limited to analyzing multiple arms together:

1. Ewing Sarcoma
2. Rhabdomyosarcoma (RMS)
3. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
4. Renal tumors
5. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

Conditions

Interventions

DRUG

Indocyanine Green

IV

Sponsors & Collaborators

Principal Investigators

  • Lindsay Talbot, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-07
Primary Completion
2026-08-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04084067 on ClinicalTrials.gov