RecruitingPhase 1NCT04084067

Indocyanine Green (ICG) Guided Tumor Resection


Sponsor

St. Jude Children's Research Hospital

Enrollment

230 participants

Start Date

Feb 7, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests a special fluorescent dye called ICG (indocyanine green) that can help surgeons see tumors more clearly during surgery. When lit up with a special light, this dye makes cancer tissue glow — helping surgeons remove all of the cancer while sparing healthy tissue. **You may be eligible if...** - You have a primary (new) or returning solid tumor or lymphoma that needs to be surgically removed - Your doctor plans to remove the tumor or cancer that has spread to other areas **You may NOT be eligible if...** - You have a history of iodine allergies - You are unable or unwilling to give consent - Your tumor is non-cancerous (benign) - You have a brain tumor - You are pregnant - You have a Wilms tumor in only one kidney Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIndocyanine Green

IV


Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT04084067


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