Patients With PSA Level 4.0 ng/mL Clinical Trial
Official title:
Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer
Primary objective :
The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection
in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation.
Secondary objective:
- Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores
- Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores
- Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy
cores
- Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores
- Evaluate FFOCT procedure time
Research in optical imaging has led to the development of the Full Field Optical Coherence
Tomography (FFOCT) technology, which allows to image fresh tissues up to a depth of a few
hundreds microns. The system is a microscope coupled with an interferometer. A halogen light
source is used to illuminate the tissue specimen and a reference mirror. The light retro
diffused by the specimen is combined with the light reflected by the mirror, and the
interference signal is measured. Multiple Grey scale images are obtained and automatically
stitched to obtain a complete slide throughout the specimen. The feasibility of the technique
has been reported in various pilot studies, as well as the absence of any potential tissue
harm and subsequent pathological artifact caused by the process.
FFOCT could be used as an additional detection tool for prostate cancer screening. The use of
extended systematic trans-rectal ultrasound-guided (TRUS) prostate biopsies has led to
over-diagnosis and over-treatment. Also, the number of unnecessary biopsies has increased,
along with the morbidity of the procedure. Performing a "pre-pathological" evaluation of
biopsy cores during the biopsy procedure would be of significant help to determine the nature
of targeted areas and guide the number of biopsies to perform.
We hypothesize that FFOCT imaging of prostate biopsy cores would allow a cancer detection
rate not statistically different from pathological analysis.
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