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)

NKI-AVL

Amsterdam, Netherlands

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NCT06666634


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