INDOCYANINE GREEN for Melanoma | Oral cavity cancer | Penile cancer

Inclusion criteria

• {"criterion_text":"- Patient who will undergo a sentinel node procedure in routine care.\n- Patients > 18 years;\n- 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\n- Patients with clinical N0 stage;\n- Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion\n- Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting."}

Exclusion criteria

• {"criterion_text":"- Patients with known allergy to patent blue dye\n- Patients who are pregnant or breast-feeding mothers\n- History of hypersensitivity reactions to products containing human serum albumin\n- History of iodine allergy\n- Hyperthyroid or thyroidal adenoma\n- Kidney insufficiency\n- Incapacity or unwillingness of participant to give written informed consent;"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Concordance assessed between SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging; expectation of an average of 3 sentinel nodes per patient. Discordance defined as more than 1 sentinel node not detected coherently by the tracers."}

Secondary endpoints

• {"endpoint_text":"- Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan); 99mTc-Nanoscan is used as reference tracer.","definition_or_measurement_approach":"Count of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT for both tracers; 99mTc-Nanoscan serves as reference tracer."}
• {"endpoint_text":"- Concordance between intraoperative fluorescence and radioactive findings, using:  Number and intensity of the fluorescent nodes at time of excision;  Number and radioactive signal intensity of the radioactive nodes at time of excision","definition_or_measurement_approach":"Concordance between intraoperative fluorescence and radioactive findings measured by: number and intensity of fluorescent nodes at excision; number and radioactive signal intensity of radioactive nodes at excision."}

Netherlands

Earliest CTIS Part Ii Submission Date

14-11-2024

Latest Decision Or Authorization Date

16-12-2024

Processing Time Days

32

Number Of Sites

1

Number Of Participants

29

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands