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
Additional locations may be listed on ClinicalTrials.gov for NCT04492735.
See trial information on ClinicalTrials.gov for a list of participating sites.
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
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationRoshni Dasgupta
