Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
NCT ID: NCT06666634
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
29 participants
INTERVENTIONAL
2023-04-01
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-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.
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Interventions
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Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Eligibility Criteria
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Inclusion Criteria
* 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 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;
18 Years
ALL
No
Sponsors
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The Netherlands Cancer Institute
OTHER
Responsible Party
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Locations
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NKI-AVL
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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N21NAN
Identifier Type: -
Identifier Source: org_study_id
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