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OpenTrials
Completed

NCT Number: NCT02910726

A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers

This study is being done in patients that have tumors to find out how well sentinel lymph nodes (SLNs) can be found with a special dye called indocyanine green (ICG).

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Key information

Conditions

Pediatric Patients With Solid Tumors

Age range

Up to 30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Memorial Sloan Kettering Cancer Center, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients <30 years old with an extracoelomic solid tumor, diagnosis confirmed at the enrolling institution, requiring SLN biopsy
  • Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
  • Patients who are cleared for surgery

Exclusion criteria

  • History of reaction to ICG, iodides, or technetium radiocolloid
  • Intracoelomic primary tumors or tumors expected to drain to an intracoelomic SLN
  • Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage
  • Patients unwilling or unable to sign informed consent
  • Women who are pregnant or breast-feeding

Treatment and study plan

Sentinel Lymph Node Biopsy

Procedure

Indocyanine Green (ICG)

Drug

Primary outcomes

  1. % of Patients in Whom a Sentinel Lymph Node is Identified

    Time frame: 1 year

    These percentages will be compared using a non-inferiority comparison for matched pair data.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Non-inferiority Study of Intra-operative Indocyanine Green Fluorescent Dye Versus Technetium Lymphoscintigraphy for Sentinel Lymph Node Biopsy in Pediatric Malignancies

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2016
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.