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Validation of ICG-99mTc-nanoscan as hybrid tracer for sentinel node biopsy
EU CTIS ID: 2024-519351-28-00
What this study is testing
To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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 likely can't join if
- Patients with known allergy to patent blue dye
- 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
- 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.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.