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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
Age
0 - 45 years
Sex
ALL
Healthy Volunteers
No
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Start Date
June 5, 2020
Primary Completion Date
December 1, 2023
Completion Date
June 1, 2025
Last Updated
July 30, 2020
45
ESTIMATED participants
Lead Sponsor
Roshni Dasgupta
NCT07112170
NCT06823167
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07115914