Metastatic Disease Clinical Trial
Official title:
The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid
Use of indocyanine green will augment the accuracy of identification and resection of both
primary solid malignancies as well as their pulmonary metastases, where applicable We will
conduct a prospective feasibility study of pediatric patients with solid malignancies with or
without lung metastatases who present at the time of initial diagnosis or relapse. These
patients will receive a targeted dye to aid in the resection of these metastases. We plan to
assess ICG as it relates to:
1. Diagnostic accuracy using pathologic correlation as gold standard measure
2. Short and long term event free and overall survival
Patients diagnosed with solid malignancies or metastatic lesions who require clinically
indicated resection will be identified by their Oncologist. The oncologist will inform the
subject/family about the study and ask if they may be interested in participating. If the
subject/family demonstrates potential interest in the study, the Pediatric Surgery Research
team will discuss the risks and benefits of pre-operative ICG administration with the
patients and enrollment.
Study subjects: All patients diagnosed with solid malignancies as well as those with
metastatic disease distant from the primary tumor will be potentially eligible for the study.
Diagnosis will be made:
1. In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI,
CT scan, etc), and sometimes biopsy.
2. Prior to definitive surgical resection of the newly diagnosed malignancy
;
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