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Completed

NCT Number: NCT02394223

FFOCT 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

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Key information

Conditions

Patients With PSA Level 4.0 ng/mL Neoplasms

Age range

45 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Assistance Publique - Hôpitaux de Paris Cochin Hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full Field Optical Coherence Tomography (FFOCT) procedure

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

Primary outcomes

  1. To evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation

    Time frame: One day (biopsy procedure)

    Presence or absence of prostate cancer on pathological examination of prostate biopsy cores

Secondary outcomes

  1. To evaluate the predictive values of FFOCT for cancer detection on prostate TRUS biopsy

    Time frame: One day (biopsy procedure)

    the positive and negative predictive values for the presence of cancer, based on the prevalence of cancer in the population studied

  2. To evaluate the value of FFOCT for cancer characterization on prostate biopsy cores

    Time frame: One day (biopsy procedure)

    Gleason score and cancer length of prostate cancer on pathological examination of each prostate biopsy cores

  3. To evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores

    Time frame: One day (biopsy procedure)

    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

  4. To evaluate the learning curve of FFOCT evaluation on prostate biopsy cores

    Time frame: One day (biopsy procedure)

    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

  5. To evaluate FFOCT procedure time

    Time frame: One day (biopsy procedure)

    the duration of FFOCT procedure

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: BIOMAGIC 01

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2015
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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