Patients With PSA Level 4.0 ng/mLBIOMAGIC 01NCT02394223
FFOCT for the Diagnosis of Prostate Cancer
An observational study of Patients With PSA Level 4.0 ng/mL, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Patients With PSA Level 4.0 ng/mL
- What is being tested?
- Full Field Optical Coherence Tomography (FFOCT) procedure
- Type of treatment
- Surgery or procedure
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2016to 27 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 45 to 75 years old, with PSA level 4.0 ng/mL
Who may be able to join
- - 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
Who cannot join
- Known prostate cancer
- Patients unable to understand the course of the study
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris Cochin Hospital
Paris, 75014
About this study
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
Read the 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
- Being tested
- Full Field Optical Coherence Tomography (FFOCT) procedure
- Keywords
- Cancer, Prostate, PSA, Biopsies, FFOCT procedure
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Field Optical Coherence Tomography (FFOCT) procedureProcedure or surgery
TRUS Prostate biopsy are performed under the care procedure Pathological examination of these prostate biopsy with FFOCT procedure, as compared to standard pathological evaluation
| Study group | Role | What they receive |
|---|---|---|
| Full Field Optical Coherence Tomography (FFOCT) procedure | Not described Receives: Procedure: Full Field Optical Coherence Tomography (FFOCT) procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One day (biopsy procedure)
Secondary outcomes (5)
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
Measured: One day (biopsy procedure)
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
Measured: One day (biopsy procedure)
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
Measured: One day (biopsy procedure)
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
Measured: One day (biopsy procedure)
To evaluate FFOCT procedure time
the duration of FFOCT procedure
Measured: One day (biopsy procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start27 Jan 2016
- Primary completion27 Jan 2017
- Study completion27 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With PSA Level 4.0 ng/mLStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Nicolas Barry Delongchamps, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394223
- Sponsor's protocol ID
- NI13012
- Other IDs
- AOK 13142
- Acronym
- BIOMAGIC 01
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2015
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer
- ClinicalTrials.gov ID
- NCT02394223
- Acronym / sponsor ID
- BIOMAGIC 01 / NI13012
- Conditions
- Patients With PSA Level 4.0 ng/mL
- Keywords
- Cancer, Prostate, PSA, Biopsies, FFOCT procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 27 Jan 2017 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Field Optical Coherence Tomography (FFOCT) procedure | – | Procedure: Full Field Optical Coherence Tomography (FFOCT) procedure |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 45 to 75 years old, with PSA level 4.0 ng/mL
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (2 listed)
- Known prostate cancer
- Patients unable to understand the course of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Field Optical Coherence Tomography (FFOCT) procedureTRUS Prostate biopsy are performed under the care procedure Pathological examination of these prostate biopsy with FFOCT procedure, as compared to standard pathological evaluation | Procedure or surgery | Full Field Optical Coherence Tomography (FFOCT) procedure |
Primary outcome
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
5 secondary outcomes
To evaluate the predictive values of FFOCT for cancer detection on prostate TRUS biopsy
Time frame: One day (biopsy procedure)
To evaluate the value of FFOCT for cancer characterization on prostate biopsy cores
Time frame: One day (biopsy procedure)
To evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores
Time frame: One day (biopsy procedure)
To evaluate the learning curve of FFOCT evaluation on prostate biopsy cores
Time frame: One day (biopsy procedure)
To evaluate FFOCT procedure time
Time frame: One day (biopsy procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Barry Delongchamps principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With PSA Level 4.0 ng/mL, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.