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Trial Title:
Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
NCT ID:
NCT06666634
Condition:
Penile Cancer
Melanoma
Oral Cancer
Conditions: Official terms:
Mouth Neoplasms
Penile Neoplasms
Conditions: Keywords:
Fluorescence
Radioactivity
Indocyanine green
Clinical node negative patients
Surgical staging
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Description:
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Arm group label:
Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan
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.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NKI-AVL
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Oscar Dr. O. Brouwer
Phone:
+31205129111
Email:
o.brouwer@nki.nl
Investigator:
Last name:
Oscar Brouwer
Email:
Principal Investigator
Start date:
April 1, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06666634
