NL-OMON54192CompletedNot Applicable
MultiSPectral fLuorescence Imaging as a Tool to separate healthy and disease related lymphatic anatomies during lymph node dissections in prostate cancer. - SPLIT study
Antoni van Leeuwenhoek Ziekenhuis0 sites28 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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