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

Netherlands Cancer Institute (NKI)

Status: Enrolling

Conditions: Melanoma; Penile Cancer; Oral Cancer

Treatments: Drug: Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan

Study type: Interventional

Funder types: Other

Identifiers

NCT06666634

N21NAN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan

Other group

Description:

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.

Treatment:

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