Prostate CancerNCT02185170
DEPORRA-CoProst: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections
A study testing Trans-urethral resection, Use of the FEMTO-ST institute medical device and Use of the Light-CT scanner in people with Prostate Cancer, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of this study is divided in 4 different steps: the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging), the second step is the adaptation of immunolabelling protocol… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Trans-urethral resection, Use of the FEMTO-ST institute medical device and Use of the Light-CT scanner
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Sep 2015
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient over 18 years old.
- Patient scheduled for trans-urethral resection of prostate with:
- prostate specific antigen (PSA) blood level ≤ 4 ng/ml and age > 80 years old
- a suspected prostate cancer after a digital rectal examination (DRE) and a PSA blood level > 50 ng/ml or an existing prostate cancer
- Patient affiliated to social security or beneficiary of such a regime.
Who cannot join
- Protected patient referred to in Articles L1121-6 to L1121-8 of the Code of Public Health
Trial locations and contacts
1 site in 1 country.
France1 site
Grenoble University Hospital, Urology and Anatomopathology Department
Grenoble, 38043
About this study
Official title: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections.
The aim of this study is divided in 4 different steps:
- the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging),
- the second step is the adaptation of immunolabelling protocol on histopathology slides, using fresh prostatic tissue,
- the third step is to validate the use of:
Read more
- the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue,
- the Light-CT scanner use for tissue structural observation.
- the four step is to check the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.
- Conditions
- Prostate Cancer
- Being tested
- Trans-urethral resection, Use of the FEMTO-ST institute medical device, Use of the Light-CT scanner
- Keywords
- Prostate, Cancer, Medical Device, Fluorescence
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-urethral resectionProcedure or surgery
All subjects of the study are going to have a trans-urethral resection of prostate.
Use of the FEMTO-ST institute medical deviceDevice
The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.
Use of the Light-CT scannerDevice
The Light-CT Scanner is use in the tissue structural observation
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence assesment | Experimental | All patients undergo a transurethral resection.
There are four different steps in the study:
* the first step: fresh prostatic tissue of 30 subjects will be use to asses the fluorescence signal and the entire chain,
* the second step: fresh prostatic tissue of 10 subjects will be used to asses the immunolabelling protocol,
* the third step: fresh prostatic tissue of 20 subjects will be used to asses the use of the FEMTO-ST institute medical device,
* the four step: the fresh prostatic tissue from the 10 subjects of the second step will be evaluated to verify the preservation of morphological structure with the use of the Light-CT scanner. Receives: Procedure: Trans-urethral resection; Device: Use of the FEMTO-ST institute medical device; Device: Use of the Light-CT scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete fluorescence measurement over each field of vision.
Determinate for the anti-PSMA antibody with Alexa Fluor 488 tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.
Measured: 1 day
Secondary outcomes (4)
Complete fluorescence measurement over each field of vision.
Determinate for the anti-PSMA antibody with R-Phycoerythrin tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.
Measured: 1 day
Quality criteria of the structure of tissue (ordinal qualitative variables).
Verification of the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.
Measured: 1 day
Fluorescence measurements mean.
Validate the medical device from "FEMTO-ST institute" for the detection of fluorescence signals on fresh prostatic tissue.
Measured: 1 day
Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides
Validate the Light-CT scanner from LLTech laboratory in the fresh prostatic tissue structural observation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Results of 5 first patients show that chips' cauterization interferes the signal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire TIMC-IMAG, FEMTO-ST Institute, LLTech laboratory, Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Descotes, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185170
- Sponsor's protocol ID
- DCIC 12 03
- Status last verified
- Sep 2015
- First submitted
- 23 Jun 2014
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections.
- ClinicalTrials.gov ID
- NCT02185170
- Acronym / sponsor ID
- DCIC 12 03
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Medical Device, Fluorescence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of 5 first patients show that chips' cauterization interferes the signal
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire TIMC-IMAG, FEMTO-ST Institute, LLTech laboratory, Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Jul 2014 (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.
The aim of this study is divided in 4 different steps:
- the first step has two different purpose: assess the impact of the storage medium of fresh prostatic chips on fluorescence signal and adjust the entire chain (immunolabelling,counter-stain and imaging),
- the second step is the adaptation of immunolabelling protocol on histopathology slides, using fresh prostatic tissue,
- the third step is to validate the use of:
- the medical device created by the FEMTO-ST institute use for the detection of fluorescence signal on fresh tissue,
- the Light-CT scanner use for tissue structural observation.
- the four step is to check the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescence assesment | Experimental | Procedure: Trans-urethral resection, Device: Use of the FEMTO-ST institute medical device, Device: Use of the Light-CT scannerAll patients undergo a transurethral resection. There are four different steps in the study: * the first step: fresh prostatic tissue of 30 subjects will be use to asses the fluorescence signal and the entire chain, * the second step: fresh prostatic tissue of 10 subjects will be used to asses the immunolabelling protocol, * the third step: fresh prostatic tissue of 20 subjects will be used to asses the use of the FEMTO-ST institute medical device, * the four step: the fresh prostatic tissue from the 10 subjects of the second step will be evaluated to verify the preservation of morphological structure with the use of the Light-CT scanner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patient over 18 years old.
- Patient scheduled for trans-urethral resection of prostate with:
- Patient affiliated to social security or beneficiary of such a regime.
Key exclusion criteria (1 listed)
- Protected patient referred to in Articles L1121-6 to L1121-8 of the Code of Public Health
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 |
|---|---|---|
| Trans-urethral resectionAll subjects of the study are going to have a trans-urethral resection of prostate. | Procedure or surgery | Fluorescence assesment |
| Use of the FEMTO-ST institute medical deviceThe FEMTO-ST institute medical device is use to detect prostatic and malignant tissue. | Device | Fluorescence assesment |
| Use of the Light-CT scannerThe Light-CT Scanner is use in the tissue structural observation | Device | Fluorescence assesment |
Primary outcome
Complete fluorescence measurement over each field of vision.
Time frame: 1 day
Determinate for the anti-PSMA antibody with Alexa Fluor 488 tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.
4 secondary outcomes
Complete fluorescence measurement over each field of vision.
Time frame: 1 day
Quality criteria of the structure of tissue (ordinal qualitative variables).
Time frame: 1 day
Fluorescence measurements mean.
Time frame: 1 day
Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Results of 5 first patients show that chips' cauterization interferes the signal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
- Website of the Grenoble Clinical Investigation Center - Technological InnovationLink provided by the sponsor.
- Website of the Techniques for biomedical engineering and complexity management - informatics, mathematics and applications - Grenoble laboratoryLink provided by the sponsor.
- Website of FEMTO-STLink provided by the sponsor.
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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.
Jean-Luc Descotes, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-urethral resection, Use of the FEMTO-ST institute medical device and Use of the Light-CT scanner in people with Prostate Cancer, run by University Hospital, Grenoble 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 1 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: stopped early, as of the sponsor's last update on 22 Sep 2015. 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 was stopped early (reason given: Results of 5 first patients show that chips' cauterization interferes the signal). Results are not available in the source record.
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?
Complete fluorescence measurement over each field of vision. (time frame: 1 day). 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 22 Sep 2015.