Actively Recruiting

Phase 1
All Genders
NCT04084067

Indocyanine Green (ICG) Guided Tumor Resection

Led by St. Jude Children's Research Hospital · Updated on 2026-04-30

230

Participants Needed

1

Research Sites

412 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Indocyanine Green (ICG) Guided Tumor Resection

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.
Not Eligible

You will not qualify if you...

  • History of iodide allergies.
  • Inability or unwillingness to give written informed consent.
  • Patients with benign pathology.
  • Patients with brain tumors.
  • Pregnant females.
  • Patients with unilateral Wilms Tumor.

AI-Screening

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Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

L

Lindsay Talbot, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Indocyanine Green (ICG) Guided Tumor Resection | DecenTrialz