Validation of ICG-99mTc-nanoscan as hybrid tracer for sentinel node biopsy

Phase 3

Conditions: head/neck/trunk melanoma
oral malignancies
penile carcinoma
10027656

Registration Number: NL-OMON51806

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

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, upper
part of the trunk, and extremities;
* Patients presenting with a primary oral cavity malignancyT1-2N0;
* 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;
* 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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To show concordance between ICG-99mTc-Nanoscan and 99mTc-Nanoscan SLN<br /><br>visualized on preoperative lymphoscintigraphy and SPECT/CT imaging, where<br /><br>concordance is defined as at most 1 sentinel node detected by one tracer being<br /><br>missed by the other tracer. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy<br /><br>and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan);<br /><br><br /><br>2. Concordance between intraoperative fluorescence and radioactive findings<br /><br>using:<br /><br>• Number and intensity of the fluorescent nodes at time of excision;<br /><br>• Number and radioactive signal intensity of the radioactive nodes at time of<br /><br>excision;</p><br>