Focal Prostate Imaging With CLE and OCT

Prostate Cancer Clinical Trial

— FPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03253458
• Other study ID #: NL57326.018.17
• Secondary ID: METC 2017_130
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: January 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Abel Swaan, MSc
• Phone: +31205668978
• Email: a.swaan[@]amc.uva.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: July 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
Netherlands	AMC University Hospital	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Safety of CLE and OCT imaging in the prostate	Procedure-related adverse events of needle based CLE and OCT	2 years