Focal Prostate Imaging With CLE and OCT (FPI)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Confocal Laser Endomicroscopy
Sponsored by

About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Optical coherence tomography, Confocal Laser Endomicroscopy, Histology
Eligibility 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
Sites / Locations
- AMC University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Optical imaging
Arm Description
All consenting patients will undergo Confocal Laser Endomicroscopy or Optical Coherence Tomography imaging prior to biopsy or surgery.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Safety of CLE and OCT imaging in the prostate
Procedure-related adverse events of needle based CLE and OCT
Full Information
NCT ID
NCT03253458
First Posted
August 7, 2017
Last Updated
January 17, 2019
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT03253458
Brief Title
Focal Prostate Imaging With CLE and OCT
Acronym
FPI
Official Title
In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Amsterdam UMC, location VUmc
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Optical coherence tomography, Confocal Laser Endomicroscopy, Histology
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Optical imaging
Arm Type
Experimental
Arm Description
All consenting patients will undergo Confocal Laser Endomicroscopy or Optical Coherence Tomography imaging prior to biopsy or surgery.
Intervention Type
Device
Intervention Name(s)
Confocal Laser Endomicroscopy
Other Intervention Name(s)
Optical Coherence Tomography
Intervention Description
Transperineal confocal laser endomicroscopy or optical coherence tomography measurements. Probe will be placed guided by ultrasound, similar procedure as transperineal template guided mapping biopsies.
Primary Outcome Measure Information:
Title
Visual image criteria for CLE and quantitative parameters (attenuation coefficient and residue) of OCT for the characterization of the prostate tissue
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Technical feasibility of CLE and OCT imaging in the prostate by a transperineal approach
Description
Tissue visualization is not blocked by blood on CLE and OCT imaging
OCT image quality determination by visibility in depth
Time Frame
2 years
Title
Safety of CLE and OCT imaging in the prostate
Description
Procedure-related adverse events of needle based CLE and OCT
Time Frame
2 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer only occurs in male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abel Swaan, MSc
Phone
+31205668978
Email
a.swaan@amc.uva.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Mannaerts, MD
Phone
+31205664377
Email
c.k.mannaerts@amc.uva.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theo M de Reijke, MD
Organizational Affiliation
AMC-UvA
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMC University Hospital
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abel Swaan, Drs. Msc.
Phone
+31 20 568978
Email
a.swaan@amc.uva.nl
First Name & Middle Initial & Last Name & Degree
Christophe Mannaerts, Drs. Msc.
Phone
+31 20 564377
Email
c.k.mannaerts@amc.uva.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35790459
Citation
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.
Results Reference
derived
PubMed Identifier
29784633
Citation
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.
Results Reference
derived
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Focal Prostate Imaging With CLE and OCT
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