No registrations found.
ID
Source
Health condition
prostate cancer sentinel node biopsy
Sponsors and support
- ERC-starting grant (2012-306890)
- Eurorad S.A. (loaner drop-in probes)
Intervention
Outcome measures
Primary outcome
- 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 outcome
- 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).
Study objective
a clinical evaluation of the two drop-in gamma probe prototypes for their ability to localize the sentinel node(s) during robot-assisted sentinel node biopsy of the prostate.
Study design
Determination of the sensitivity of the prototype drop-in probe for (robot-assisted) laparoscopic sentinel node(s) identification after the inclusion of 25 patients
Intervention
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(s).
Intraoperatively, after anesthetizing the patient, sentinel node biopsy will be performed. For this drop-in probe will be used. The
sentinel node(s) will be localised using the conventional methods (laparoscopic gamma probe and fluorescence camera) and the
drop-in probe.
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6289 |
| NTR-old | NTR6463 |
| CCMO | NL5738.031.16 |