Focal Prostate Imaging With CLE and OCT

NCT03253458 | Unknown FDA Device

• 2 other identifiers: NL57326.018.17METC 2017_130
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Optical coherence tomography; Confocal Laser Endomicroscopy; Histology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Technical feasibility of CLE and OCT imaging in the prostate by a transperineal approach

  2 years

• Safety of CLE and OCT imaging in the prostate

  2 years

Study Arms (1)

Optical imaging

EXPERIMENTAL

All consenting patients will undergo Confocal Laser Endomicroscopy or Optical Coherence Tomography imaging prior to biopsy or surgery.

Device: Confocal Laser Endomicroscopy

Interventions

Confocal Laser Endomicroscopy DEVICE

Transperineal confocal laser endomicroscopy or optical coherence tomography measurements. Probe will be placed guided by ultrasound, similar procedure as transperineal template guided mapping biopsies.

Also known as: Optical Coherence Tomography

Optical imaging

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer only occurs in male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Amsterdam UMC, location VUmc: collaborator

Study Sites (1)

AMC University Hospital

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 35790459 DERIVED

• 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.

  PMID: 29784633 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Theo M de Reijke, MD

  AMC-UvA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abel Swaan, MSc

CONTACT

+31205668978; a.swaan@amc.uva.nl

Christophe Mannaerts, MD

CONTACT

+31205664377; c.k.mannaerts@amc.uva.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Theo M. de Reijke

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 18, 2017
• Study Start: May 11, 2018
• Primary Completion: December 31, 2019
• Study Completion: July 1, 2020
• Last Updated: January 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)