Status:
UNKNOWN
Focal Prostate Imaging With CLE and OCT
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Amsterdam UMC, location VUmc
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 (OC...
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 mapp...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03253458
Start Date
May 11 2018
End Date
July 1 2020
Last Update
January 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AMC University Hospital
Amsterdam, North Holland, Netherlands, 1105 AZ