schildwachtklieronderzoek bij hoofd-hals maligniteiten (M/V), penis en prostaat kanker sentinel node biopsy
Conditions
Interventions
According to the current standard, on the afternoon prior to, or on the morning
of surgery, ICG-99mTc-nanocolloid will be injected peritumorally sub- or
intracutaneously (patients with prostate canc
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients > 18 years of age; - Patients with histologically proven head and neck malignancies; - Patients with histologically proven penile cancer; - Patients with histologically proven prostate cancer; - Patients are clinically N0M0 (penile cancer: N0M0 or N1M0); - For head and neck malignancies and penile cancer patients only: Patients are scheduled for (primary) tumor (scar) removal with a subsequent sentinel node biopsy; - For prostate cancer patients only: Patients with an increased risk of nodal metastases according to the Briganti nomogram (>10%); - For prostate cancer patients only: Patients are scheduled for (robot-assisted) laparoscopic prostatectomy with a subsequent sentinel node biopsy procedure and selective lymph node dissection.
Exclusion criteria
Exclusion criteria: - History of iodine allergy; - Hyperthyroid or thyroidal adenoma; - Kidney insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The intraoperative sentinel node identificaton rate using the opto-nuclear probe via 1) gamma tracing; and 2) via fluorescence tracing. Obtained results will be compared tot hat of the gamma camera and the fluorescence camera (routinely used methods). | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Outcome results
None listed