Focal Prostate Imaging With CLE and OCT (FPI)
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|ClinicalTrials.gov Identifier: NCT03253458|
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : January 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Confocal Laser Endomicroscopy||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography|
|Actual Study Start Date :||May 11, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||July 1, 2020|
Experimental: Optical imaging
All consenting patients will undergo Confocal Laser Endomicroscopy or Optical Coherence Tomography imaging prior to biopsy or surgery.
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.
Other Name: Optical Coherence Tomography
- Visual image criteria for CLE and quantitative parameters (attenuation coefficient and residue) of OCT for the characterization of the prostate tissue [ Time Frame: 2 years ]
- 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
- Technical feasibility of CLE and OCT imaging in the prostate by a transperineal approach [ Time Frame: 2 years ]
- 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 [ Time Frame: 2 years ]Procedure-related adverse events of needle based CLE and OCT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253458
|Contact: Abel Swaan, MScemail@example.com|
|Contact: Christophe Mannaerts, MDfirstname.lastname@example.org|
|AMC University Hospital||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1105 AZ|
|Contact: Abel Swaan, Drs. Msc. +31 20 568978 email@example.com|
|Contact: Christophe Mannaerts, Drs. Msc. +31 20 564377 firstname.lastname@example.org|
|Principal Investigator:||Theo M de Reijke, MD||AMC-UvA|