NL-OMON52846
Completed
Not Applicable
ear-infrared fluorescence imaging using indocyanine green as an adjunct to improve standard-of-care sentinel lymph node procedure in pediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular or extremities: a feasibility trial - ICG to improve sentinel lymph node procedure in pediatric patients
Prinses Máxima Centrum voor Kinderoncologie0 sites22 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Prinses Máxima Centrum voor Kinderoncologie
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pediatric patients with melanoma or sarcoma of head/neck/trunk, paratesticular
- •or extremities that have an indication for a sentinel node procedure.
- •Age 0\-18 years.
- •Written informed consent from patient/parents/legal guardians, according to
- •local law and regulations.
Exclusion Criteria
- •1\. Allergy to iodine
- •2 Hypersensitivity to ICG
- •3\. Kidney insufficiency (eGFR\<55\)
- •4\. Clinical manifest hyperthyroidism/ autonomous thyroid adenoma
- •5\. Nanocolloid or shell fish allergy (same as in standard care: or
- •Technetium\-nanocolloid use)
Outcomes
Primary Outcomes
Not specified
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