NCT06666634

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Penile Cancer
• Melanoma
• Oral Cancer

Interventions

Type	Name	Description
DRUG	Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan	Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

1 site across 1 country: Netherlands