Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT06666634
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06666634
Study Brief:
Protocol Section:
NCT06666634