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Clinical evaluation of a prototype drop-in gamma probe for sentinel node biopsy


- candidate number27311
- NTR NumberNTR6463
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mei-2017
- Secondary IDsNL5738.031.16 
- Public TitleClinical evaluation of a prototype drop-in gamma probe for sentinel node biopsy
- Scientific TitleClinical evaluation of a prototype drop-in gamma probe for (robot-assisted) laparoscopic sentinel node biopsy
- ACRONYM
- hypothesisa 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.
- Healt Condition(s) or Problem(s) studiedProstatic neoplasms, Sentinel node biopsy
- Inclusion criteriaIn 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 criteriaA 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jul-2017
- planned closingdate1-okt-2018
- Target number of participants25
- InterventionsOn 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.
- 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).
- TimepointsDetermination of the sensitivity of the prototype drop-in probe for (robot-assisted) laparoscopic sentinel node(s) identification after the inclusion of 25 patients
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES P. Meershoek
- CONTACT for SCIENTIFIC QUERIES H.G. Poel, van der
- Sponsor/Initiator NKI-AVL
- Funding
(Source(s) of Monetary or Material Support)
NWO-STW-VIDI (Grant No. STW BGT11272) , ERC-starting Grant (Grant No. 2012-306890), Eurorad S.A.
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD23-mei-2017 - 3-jul-2017


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