MultiSPectral fLuorescence Imaging as a Tool to separate healthy and disease related lymphatic anatomies during lymph node dissections in prostate cancer.

Completed

Conditions: Prostate cancer
10038597

Registration Number: NL-OMON54192

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 28

Inclusion Criteria

* Male, aged >= 18 years.
* WHO performance status 0,1, or 2.
* Written informed consent.
* Histopathologically confirmed adenocarcinoma of the prostate
* Increased risk of nodal metastases according to the MSKCC nomogram (> 7%)
* Scheduled for surgical (laparoscopic) prostatectomy including ePLND
* Suitable for RP and ePLND, as per institutional guidelines

Exclusion Criteria

* Prostate cancer patients with prior abdominal or inguinal surgery
* History of allergy to iodine, food or medicinal induced urticaria, asthma,
eczema, or aller-gic rhinitis
* Hyperthyroid or thyroidal adenoma
* Kidney insufficiency
* History of oversensitivity to FLUORESCITE composites
* Patients using beta-blockers

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Determine the technical feasibility of using multispectral fluorescence<br /><br>imaging to distinguish between two lymphatic drainage patterns LNLower<br /><br>limb/abdominal wall (fluorescein) and LNprostate (ICG-99mTc- nanocolloid)) in<br /><br>prostate cancer patients scheduled for RALP + ePLND + SN us-ing the Firefly Si<br /><br>laparoscope (da Vinci Si®) and/or Image 1 HUB HD + D-light P (Karl Storz)<br /><br>system.<br /><br>- Determine whether and where the lymphatic drainage profile of the lower<br /><br>limbs/abdominal wall converge with the drainage profile of the primary tumor:<br /><br>are there lymph nodes containing both fluorescein and ICG-99mTc- nanocolloid </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Correlate pathological tumour findings in the excised nodal specimens with<br /><br>the presence of ICG-99mTc- nanocolloid or fluorescein (or lack thereof) in<br /><br>order to assess if separation of the lymphatic drainage pathways in fact also<br /><br>means that no metastases are found in LNLower limb/abdominal wall<br /><br>(fluorescein).<br /><br>- Determine whether fluorescein is also found in lymph nodes in ePLND template<br /><br>on contralateral side of injection in lower limb/abdominal wall<br /><br>- Determine the anatomical relationship between the lymphatic drainage profile<br /><br>of the lower limbs/abdominal wall and the sentinel node of the primary tumor<br /><br>- Determine lymph fluid leakage by measuring this during surgery as this can be<br /><br>a predictive factor for complications:<br /><br>o Leakage yes/no?<br /><br>o Yes: <1cm from lymphnode?<br /><br>o Yes: >1cm from lymphnode?<br /><br><br /><br>*</p><br>