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New treatment option for Penile Cancer
Official title Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
ClinicalTrials.gov ID: NCT06666634
What this study is testing
What is Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan?
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan is an investigational medicine, being studied as a potential treatment for penile cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.