Skip to main content
OpenTrials
Completed

NCT Number: NCT06666634

Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy

99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.

Completed

Looking for future studies?

Notify Me

Key information

About this study

The investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of ICG-99mTc-Nanocolloid (99mTc-Nanocoll vs. ICG-99mTc-Nanocoll (NL26699.031.09 -N09DRF). In particular, the investigators want to validate that the hybrid ICG-99m Tc-Nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. All this to maintain the level of current care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient who will undergo a sentinel node procedure in routine care.
  • Patients > 18 years;
  • Patients presenting with:
  • a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities;
  • OR patients presenting with a primary oral cavity malignancy T1-2N0
  • OR patients with primary penile cancer
  • Patients with clinical N0 stage;
  • Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion;
  • Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting

Exclusion criteria

  • Patients with known allergy to patent blue dye or nanocolloid;
  • Patients who are pregnant or breast-feeding mothers;
  • History of hypersensitivity reactions to products containing human serum albumin;
  • History of iodine allergy
  • Hyperthyroid or thyroidal adenoma
  • Kidney insufficiency
  • Incapacity or unwillingness of participant to give written informed consent;

Treatment and study plan

Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan

Drug

Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan

Primary outcomes

  1. Concordance between tracers

    Time frame: Measured at pre-operative imaging

    To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.

Secondary outcomes

  1. Higher echelon nodes

    Time frame: Measured at pre-operative imaging

    Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan);

  2. Concordance between intraoperative fluorescence and radioactive findings

    Time frame: Measured at pre-operative imaging

    Number of the fluorescent nodes at time of excision;

    • Number and radioactive signal intensity of the radioactive nodes at time of excision;
  3. Concordance between intraoperative fluorescence and radioactive findings

    Time frame: Measured at pre-operative imaging

    intensity of the fluorescent nodes at time of excision;

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Acronym: NANOSCAN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Jul 22, 2026

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.

Published trials that share one or more normalized conditions with this study.