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

Recruiting

• Conditions: Primary Tumor; Metastatic Disease; Solid Malignancies

• Registration Number: NCT04492735
• Lead Sponsor: Roshni Dasgupta

Brief 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

Study Timeline

• Study Start: 2020-06-05
• Status Verified: 2020-07
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30
• Primary Completion: 2023-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

All patients with newly diagnosed solid, primary malignancies or their related metastatic lesions.

Diagnosis of primary or metastatic malignancy will be made by combination of:

1. Clinical evaluation and physical exam
2. Radiologic study including ultrasound, CT scan, and/or MRI
3. Pathologic diagnosis after biopsy

Exclusion Criteria

1. Those patients and parents/guardians unwilling to provide consent/assent.
2. Pregnant and/or women who are breast feeding.
3. Patients with Iodine allergies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy using pathologic correlation as gold standard measure	2 years
Short and long term event free and overall survival	2 years

Trial Locations

Locations (1)

Cincinnati Childrens Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States