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van CCT (UK)

van CCT (UK)

ICG-99mTc-nanocolloid vs. 99mTc-nanocolloid en een intraoperatieve injectie van ICG voor de schildwachtklierprocedure van prostaat kanker.

- candidate number19288
- NTR NumberNTR4733
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2014
- Secondary IDsM13PSN NL46580.031.13
- Public TitleICG-99mTc-nanocolloid vs. 99mTc-nanocolloid en een intraoperatieve injectie van ICG voor de schildwachtklierprocedure van prostaat kanker.
- Scientific TitleICG-99mTc-nanocolloid vs. 99mTc-nanocolloid and and intraoperative ICG injection for sentinel node biopsy in patients with prostate cancer
- hypothesisIntraoperative fluorescence imaging alone is sufficient to identify the sentinel nodes of the prostate as seen with preoperative radiocolloid-based sentinel node mapping
- Healt Condition(s) or Problem(s) studiedProstatic neoplasms, Prostate cancer, Sentinel lymph node localization, Sentinel node biopsy
- Inclusion criteria- patients >18 years of age
- patients with histologically proven prostate cancer
- patients with an increased risk of nodal metastasis according to the MSKCC nomogram (>10%)
- scheduled for surgical (laparoscopic) prostatectomy including nodal dissection
- Exclusion criteria- patients with a history of iodine allergy
- patients with a hyperthyroid or thyroidal adenoma
- patients with kidney insufficiency
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2014
- planned closingdate1-jul-2016
- Target number of participants138
- InterventionsOn the morning of surgery patients will receive an transrectal-ultrasound guided intraprostatic or intratumoral injection with the hybrid tracer ICG-99mTc-nanocolloid (ARM 1) or 99mTc-nanocolloid (ARM 2). Thereafter, preoperative imaging will be performed: static lymphoscintigraphy (15min and 2hrs p.i.) and SPECT-CT imaging (2hrs p.i.). The nuclear medicine physician will evaluate the images and determine the number and location of the sentinel node(s).
Prior to the start of the operation, the patients in ARM 2 will receive an intraprostatic ICG injection. Then SN biopsy is performed. Intraoperatively, SNs will be initially pursued via fluorescence imaging alone. After identification of all fluorescent SNs the urologist will evaluate the preoperative images (lymphoscintigraphy and SPECT/CT) to confirm removal of all preoperatively defined SNs. Thereafter, with the conventional gamma probe the area of resection will be checked for any remaining hot nodes. If there are any remaining SNs left in situ, these SNs will also be removed. After removal and documentation of all preoperatively defined SNs the subsequent extensive nodal dissection will be performed followed by the prostatectomy.
- Primary outcomeNumber of tumor positive lymph nodes.
- Secondary outcome-
- Timepoints-
- Trial web site-
- statusopen: patient inclusion
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL), NWO (VIDI grant)
- Publicationsvan der Poel et al, Eur Urol 2012; Jeschke et al., Urology 2012
- Brief summaryRecently fluorescent dyes such as indocyanine green (ICG) have been introduced into clinical practice for fluorescence-based sentinel node (SN) biopsy in a variety of malignancies, amongst others prostate cancer. A study by Jeschke et al. [Jeschke et al., Urology 2012] showed that intraoperative fluorescence imaging allowed SN and lymphatic duct visualization in prostate cancer. However, it did not allow for preoperative SN mapping; the limited tissue penetration of the fluorescence signal prohibits this. With the introduction of a hybrid tracer, in which ICG is coupled to the conventional radiocolloid 99mTc-nanocolloid, our group showed that with this tracer preoperative SN mapping was possible. In addition, intraoperatively, the fluorescence signature allowed for optical SN identification [van der Poel et al., Eur Urol 2012]. Logistical reasons, but also the fact that not every medical center has a highly skilled nuclear medicine department, lead to the suggestion that intraoperative fluorescence imaging can possibly replace the preoperatively radiocolloid-based method.
- Main changes (audit trail)
- RECORD12-aug-2014 - 3-sep-2014

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