FFOCT for the Diagnosis of Prostate Cancer

NCT ID: NCT02394223

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 91 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-27
• Study Completion Date: 2017-01-27

Brief 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

Detailed 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.

Conditions

Patients With PSA Level 4.0 ng/mL

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Full Field Optical Coherence Tomography (FFOCT) procedure

Full Field Optical Coherence Tomography (FFOCT) procedure

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Barry Delongchamps

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Assistance Publique - Hôpitaux de Paris Cochin Hospital

Paris, , France

Countries

France

Other Identifiers

AOK 13142

Identifier Type: -

Identifier Source: org_study_id