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Focal Prostate Imaging With CLE and OCT (FPI)

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ClinicalTrials.gov Identifier: NCT03253458
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
VU University Medical Center
Information provided by (Responsible Party):
Dr. T.M. de Reijke, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Confocal Laser Endomicroscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


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 Name: Optical Coherence Tomography




Primary Outcome Measures :
  1. Visual image criteria for CLE and quantitative parameters (attenuation coefficient and residue) of OCT for the characterization of the prostate tissue [ Time Frame: 2 years ]
    • 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


Secondary Outcome Measures :
  1. Technical feasibility of CLE and OCT imaging in the prostate by a transperineal approach [ Time Frame: 2 years ]
    • Tissue visualization is not blocked by blood on CLE and OCT imaging
    • OCT image quality determination by visibility in depth

  2. Safety of CLE and OCT imaging in the prostate [ Time Frame: 2 years ]
    Procedure-related adverse events of needle based CLE and OCT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer only occurs in male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253458


Contacts
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Contact: Abel Swaan, MSc +31205668978 a.swaan@amc.uva.nl
Contact: Christophe Mannaerts, MD +31205664377 c.k.mannaerts@amc.uva.nl

Locations
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Netherlands
AMC University Hospital Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Abel Swaan, Drs. Msc.    +31 20 568978    a.swaan@amc.uva.nl   
Contact: Christophe Mannaerts, Drs. Msc.    +31 20 564377    c.k.mannaerts@amc.uva.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University Medical Center
Investigators
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Principal Investigator: Theo M de Reijke, MD AMC-UvA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. T.M. de Reijke, Theo M. de Reijke, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03253458     History of Changes
Other Study ID Numbers: NL57326.018.17
METC 2017_130 ( Other Identifier: AMC-UvA )
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr. T.M. de Reijke, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Optical coherence tomography
Confocal Laser Endomicroscopy
Histology
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases