Indocyanine Green (ICG) Guided Tumor Resection
Indocyanine Green (ICG) Guided Tumor Resection
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. Ewing Sarcoma

 3. Rhabdomyosarcoma (RMS)

 4. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

 5. Neuroblastoma

 6. Renal tumors

 7. Metastatic pulmonary deposits

 8. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

 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.
This trial is a single center open-label study. Patients with a solid tumor or lymphoma who
 require resection either for therapeutic or diagnostic intent will be included.

 Indocyanine Green (ICG) is an FDA-approved drug. Prior to surgery, patients will receive a
 single dose of ICG intravenously.

 During surgery, after the surgeon identifies the mass through visual (seen with the naked
 eye) and or tactile methods (palpated), the patient will have his/her tumor field imaged by
 Iridium system optimized for detection of ICG (Visionsense Corp, Philadelphia, PA). The
 entire procedure will be photo- documented and recorded.

 The Visionsense system records images in real time, calculates percentages, and captures the
 data. At least three different areas of the tumor will be measured. If the tumor cannot be
 identified by visual inspection or palpation, NIR-imaging will be used in an attempt to
 locate the lesion. The surrounding area will be inspected and measured to screen for
 additional sites of metastatic disease. After tumor resection, residual fluorescence in the
 surgical resection bed will be measured.

 Direct subject participation in the trial will last for the period of time from injection of
 the ICG the day before surgery and until 24 hours post-surgery.
Inclusion Criteria:

 -  Patients with a primary or relapsed solid tumor or lymphoma who require excision of
 the tumor or metastatic lesions.

 Exclusion Criteria:

 -  Subjects with a history of iodide allergies, including positive allergic reaction to
 the screening iodine test.

 -  Inability or unwillingness of research participant or legal guardian/representative to
 give written informed consent.

 -  Patients with benign pathology.

 -  Patients with brain tumors.

 -  Pregnant female.