Focal Prostate Imaging With CLE and OCT (FPI)

In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography

The current limitations in prostate cancer diagnostics lead to over- and undertreatment for a significant fraction of patients. Confocal Laser Endomicroscopy (CLE) and Optical Coherence Tomography (OCT) are focal imaging modalities with potential for in-vivo prostate imaging. The investigators anticipate that integrating focal imaging with MRI/TRUS fusion will further improve prostate cancer detection and provides a real-time histopathological threedimensional representation of the tumor lesions.

This is an investigator-initiated, prospective in-vivo safety and feasibility study with transperineal template mapping biopsies (TTMB) and two focal imaging methods, CLE and OCT, in prostate tissue.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Confocal Laser Endomicroscopy

Detailed Description

Study design:

This is an investigator-initiated, prospective in-vivo safety and feasibility study with two procedures.

Procedure 1 (AMC):

Patients that are indicated for transperineal template mapping biopsies (TTMB) are included for procedure 1 and will receive transperineal CLE or OCT measurements prior to TTMB. Procedure 1 is to test the technical feasibility and safety of in-vivo focal imaging with CLE and OCT. Only if transperineal CLE or OCT measurements are possible, the investigators proceed with procedure 2.

For procedure 1: 4 patients that are scheduled for TTMB; 2 patients for CLE and 2 patients for OCT.

Procedure 2 (VUmc):

Patients scheduled for a robot-assisted laparoscopic prostatectomy (RALP) will be included in procedure 2 and receive transperineal CLE or OCT measurements prior to their surgery. Results will be correlated with histology by correlating biopsies during the TTMB procedure or with RALP the measurement trajectory will be marked. After the RALP, the prostate will be cut exactly through the measurement trajectory for whole mount coupes. In high-risk of high-intermediate-risk patients receiving an extended pelvic lymph node dissection with the RALP, ex-vivo CLE measurements will be performed.

For procedure 2: 10 patients that are scheduled for RALP; 5 patients for CLE and 5 patients for OCT. Intervention: Transperineal CLE or OCT measurements will be performed directly prior to the TTMB or RALP. The CLE and OCT probes are inserted by a needle with the same diameter as a biopsy gun. In the case of RALP, measurement trajectories will be marked for histopathology correlation.

Intervention:

Transperineal CLE or OCT measurements will be performed directly prior to the TTMB or RALP. The CLE and OCT probes are inserted by a needle with the same diameter as a biopsy gun. In the case of RALP, measurement trajectories will be marked for histopathology correlation.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Recruiting
      • AMC University Hospital
      • Contact: Abel Swaan, Drs. Msc.; Phone Number: +31 20 568978; Email: a.swaan@amc.uva.nl
      • Contact: Christophe Mannaerts, Drs. Msc.; Phone Number: +31 20 564377; Email: c.k.mannaerts@amc.uva.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion criteria

• age ≥ 18 years
• signed informed consent
• mpMRI data available

Exclusion criteria

• Patients with a known allergic reaction to fluorescein cannot participate in this study.
• Documented acute prostatitis or urinary tract infections
• No ability to stop anticoagulant or antiplatelet therapy
• Medical history of a bleeding disorder or if available platelet Count <140/uL, prothrombin time >14.5 sec., partial thromboplastin time >34 sec.
• Major concurrent debilitating illness or ASA ≥4
• Biological or chemotherapy for PCa
• Hormonal therapy within last six months
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
• Is incapable of understanding the language in which the information for the patient is given

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optical imaging; All consenting patients will undergo Confocal Laser Endomicroscopy or Optical Coherence Tomography imaging prior to biopsy or surgery.	Device: Confocal Laser Endomicroscopy; Transperineal confocal laser endomicroscopy or optical coherence tomography measurements. Probe will be placed guided by ultrasound, similar procedure as transperineal template guided mapping biopsies.; Other Names: Optical Coherence Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual image criteria for CLE and quantitative parameters (attenuation coefficient and residue) of OCT for the characterization of the prostate tissue	Describing visual characteristics on CLE imaging; Attenuation coefficient on OCT imaging calculated with our in-house build software; Residue of the OCT imaging calculated with our in-house build software	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical feasibility of CLE and OCT imaging in the prostate by a transperineal approach	Tissue visualization is not blocked by blood on CLE and OCT imaging; OCT image quality determination by visibility in depth	2 years
Safety of CLE and OCT imaging in the prostate	Procedure-related adverse events of needle based CLE and OCT	2 years

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Theo M de Reijke, MD, AMC-UvA

Publications and helpful links

General Publications

• van Riel LAMJG, Swaan A, Mannaerts CK, van Kollenburg RAA, Savci Heijink CD, de Reijke TM, de Bruin DM, Freund JE. Image-guided in-Vivo Needle-Based Confocal Laser Endomicroscopy in the Prostate: Safety and Feasibility Study in 2 Patients. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221093149. doi: 10.1177/15330338221093149.
• Swaan A, Mannaerts CK, Scheltema MJ, Nieuwenhuijzen JA, Savci-Heijink CD, de la Rosette JJ, van Moorselaar RJA, van Leeuwen TG, de Reijke TM, de Bruin DM. Confocal Laser Endomicroscopy and Optical Coherence Tomography for the Diagnosis of Prostate Cancer: A Needle-Based, In Vivo Feasibility Study Protocol (IDEAL Phase 2A). JMIR Res Protoc. 2018 May 21;7(5):e132. doi: 10.2196/resprot.9813.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Histology; Confocal Laser Endomicroscopy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: NL57326.018.17; METC 2017_130 (Other Identifier: AMC-UvA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes