Metastatic Disease Clinical Trial
Official title:
The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid
NCT number | NCT04492735 |
Other study ID # | PSORC ICG |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 5, 2020 |
Est. completion date | June 2025 |
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
Status | Recruiting |
Enrollment | 45 |
Est. completion date | June 2025 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Roshni Dasgupta |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy using pathologic correlation as gold standard measure | 2 years | ||
Primary | Short and long term event free and overall survival | 2 years |
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