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Clinical Trials/NL-OMON52846
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
Prinses Máxima Centrum voor Kinderoncologie

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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