Focal Prostate Imaging With CLE and OCT (FPI)

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

Status

Unknown

Conditions

Prostate Cancer

Treatments

Device: Confocal Laser Endomicroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT03253458

NL57326.018.17

METC 2017_130 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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