Focal Prostate Imaging With CLE and OCT

NCT ID: NCT03253458

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-11
• Study Completion Date: 2020-07-01

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Optical imaging

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

Group Type: EXPERIMENTAL

Confocal Laser Endomicroscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Optical Coherence Tomography

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Dr. T.M. de Reijke

Theo M. de Reijke

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theo M de Reijke, MD

Role: PRINCIPAL_INVESTIGATOR

AMC-UvA

Locations

AMC University Hospital

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Abel Swaan, MSc

Role: CONTACT

a.swaan@amc.uva.nl

+31205668978

Christophe Mannaerts, MD

Role: CONTACT

c.k.mannaerts@amc.uva.nl

+31205664377

Facility Contacts

Abel Swaan, Drs. Msc.

Role: primary

a.swaan@amc.uva.nl

+31 20 568978

Christophe Mannaerts, Drs. Msc.

Role: backup

c.k.mannaerts@amc.uva.nl

+31 20 564377

References

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.

Reference Type: DERIVED

PMID: 35790459 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29784633 (View on PubMed)

Other Identifiers

METC 2017_130

Identifier Type: OTHER

Identifier Source: secondary_id

NL57326.018.17

Identifier Type: -

Identifier Source: org_study_id