NCT04492735

The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies

The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Roshni Dasgupta · Academic / Other
• Sex: All
• Age: 1 Day – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Metastatic Disease
• Primary Tumor
• Solid Malignancies

Timeline

• Start date: 2020-06-05
• Primary completion: 2023-12-01
• Completion: 2025-06-01
• First posted: 2020-07-30
• Last updated: 2020-07-30

Locations

1 site across 1 country: United States