prostate cancer sentinel node biopsy
Conditions
Interventions
On the morning of surgery, ICG-99mTc-nanocolloid will be injected intraprostatically. Lymphoscintigrams and SPECT/CT imaging will be performed to determine the number and location of the sentinel node
Sponsors
NKI-AVL
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients > 18 years of age; - Patients with histologically proven prostate cancer; - Patients are clinically N0M0 or NxMx; - Patients are scheduled for (robot-assisted) laparoscopic sentinel node biopsy.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients with a history of iodine allergy; - Patients with a hyperthyroid or thyroidal adenocarcinoma; - Patients with kidney insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Determination of the sensitivity of the prototype drop-in probe for (robot-assisted) laparoscopic sentinel node(s) identification. -Determination of the work-ability of the drop-in probe during (robot-assisted) laparoscopic sentinel node biopsy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Evaluation of the ease of gripping prototype drop-in probe; - Evaluation of the maneuverability of the prototype drop-in probe; - Identification of (tumor-positive) sentinel node(s). | — |
Contacts
Public ContactP. Meershoek
Outcome results
None listed