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.
ID
Bron
Aandoening
prostate cancer sentinel node biopsy
Ondersteuning
- ERC-starting grant (2012-306890)
- Eurorad S.A. (loaner drop-in probes)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Determination of the sensitivity of the prototype drop-in probe for (robot-assisted) laparoscopic sentinel node(s) identification. <br>
- Determination of the work-ability of the drop-in probe during (robot-assisted) laparoscopic sentinel node biopsy.
Doel van het onderzoek
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.
Onderzoeksopzet
Determination of the sensitivity of the prototype drop-in probe for (robot-assisted) laparoscopic sentinel node(s) identification after the inclusion of 25 patients
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6289 |
| NTR-old | NTR6463 |
| CCMO | NL5738.031.16 |