RecruitingNot ApplicableNCT06666634
Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
Sponsor
The Netherlands Cancer Institute
Enrollment
29 participants
Start Date
Apr 1, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a new imaging tracer called ICG-99mTc-nanoscan that combines two types of dye — one visible under special light and one detectable by a radiation scanner — to help surgeons find and remove the first lymph node that cancer may have spread to (called a sentinel node). The goal is to see whether this combined tracer works as well or better than current methods.
**You may be eligible if...**
- You are 18 or older
- You have melanoma on the head, neck, upper trunk, or limbs; early-stage oral cavity cancer; or penile cancer
- You have no known spread to nearby lymph nodes (clinical N0 stage)
- You are scheduled to have a sentinel lymph node biopsy
**You may NOT be eligible if...**
- You are allergic to patent blue dye or nanocolloid
- You are pregnant or breastfeeding
- You have had reactions to products containing human albumin
- You have an iodine allergy, overactive thyroid, thyroid nodule, or kidney problems
Talk to your doctor to see if this trial is right for you.
This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interventions
DRUGSentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06666634
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