NCT06666634 Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
| NCT ID | NCT06666634 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Penile Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 29 participants in total. It began in 2023-04-01 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06666634 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Penile Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06666634 currently recruiting?
Yes, NCT06666634 is actively recruiting participants. Contact the research team at o.brouwer@nki.nl for enrollment information.
Where is the NCT06666634 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06666634 clinical trial?
NCT06666634 is sponsored by The Netherlands Cancer Institute. The trial plans to enroll 29 participants.
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