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Clinical Trials/NL-OMON54192
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

Sponsor
Antoni van Leeuwenhoek Ziekenhuis

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