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

Not Applicable

Recruiting

• Conditions: Penile Cancer; Melanoma; Oral Cancer
• Interventions: Drug: Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan

• Registration Number: NCT06666634
• Lead Sponsor: The Netherlands Cancer Institute

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-01
• Study Start: 2023-04-01
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan	Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan	The patient first receives a one-time injection with 99mTc-nanoscan, then a one-time injection with ICG-99mTc-nanoscan, both dosage are according to routine care.

Primary Outcome Measures

Name	Time	Method
Concordance between tracers	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 Outcome Measures

Name	Time	Method
Higher echelon nodes	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);
Concordance between intraoperative fluorescence and radioactive findings	Measured at pre-operative imaging	intensity of the fluorescent nodes at time of excision;

Trial Locations

Locations (1)

NKI-AVL; 🇳🇱 Amsterdam, Netherlands