FFOCT for the Diagnosis of Prostate Cancer

Patients With PSA Level 4.0 ng/mL Clinical Trial

— BIOMAGIC01  

Official title:

Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394223
• Other study ID #: AOK 13142
• Status: Completed
• First received: March 16, 2015
• Last updated: March 16, 2018
• Start date: January 27, 2016
• Est. completion date: January 27, 2017

Study information

• Verified date: March 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 27, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• - Patient aged 45 to 75 years old included

• - PSA level 4.0 ng/mL

• - Patient referred for trans rectal ultrasound-guided prostate biopsy with additional MRI-targeted biopsies

• - Patient no opposed to participate in the study

• Patient affiliated to the French National Social Security System

Exclusion Criteria:

• Known prostate cancer

• Patients unable to understand the course of the study

Related Conditions & MeSH terms

• Patients With PSA Level 4.0 ng/mL
• Prostatic Neoplasms

Intervention

Procedure:
• Full Field Optical Coherence Tomography (FFOCT) procedure
TRUS Prostate biopsy are performed under the care procedure Pathological examination of these prostate biopsy with FFOCT procedure, as compared to standard pathological evaluation

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation	Presence or absence of prostate cancer on pathological examination of prostate biopsy cores	One day (biopsy procedure)
Secondary	To evaluate the predictive values of FFOCT for cancer detection on prostate TRUS biopsy	the positive and negative predictive values for the presence of cancer, based on the prevalence of cancer in the population studied	One day (biopsy procedure)
Secondary	To evaluate the value of FFOCT for cancer characterization on prostate biopsy cores	Gleason score and cancer length of prostate cancer on pathological examination of each prostate biopsy cores	One day (biopsy procedure)
Secondary	To evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores	the inter observer agreement for the diagnosis of cancer between 2 experienced pathologists fully trained to the technique, as well as 2 experienced urologists trained to the technique	One day (biopsy procedure)
Secondary	To evaluate the learning curve of FFOCT evaluation on prostate biopsy cores	the evolution of the diagnostic performance with time when FFOCT images are evaluated with an experienced pathologist untrained to the technique before the beginning of the study	One day (biopsy procedure)
Secondary	To evaluate FFOCT procedure time	the duration of FFOCT procedure	One day (biopsy procedure)