Actively Recruiting
Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
Led by The Netherlands Cancer Institute · Updated on 2024-10-30
29
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient who will undergo a sentinel node procedure in routine care
- Patients older than 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
NKI-AVL
Amsterdam, Netherlands
Actively Recruiting
Research Team
O
Oscar Brouwer, Dr.
CONTACT
D
Daphne Rietbergen, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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