Cancer of the ProstateEFELNCT02879851
Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound Obtained in Vivo by the Koelis™ System
An observational study of Cancer of the Prostate, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The study aims at quantifying the registration error obtained in routine patients in different parts of the prostate and for operators with different experience in order to assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer of the Prostate
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prostate cancer referred for placement of intraprostatic fiducials before prostate radiotherapy
Who may be able to join
- Age ≥ 18 years
- Patient requiring placement of intraprostatic fiducials
- No contra-indication for fiducials placement
- No contra -indication to MRI
- No contra -indication for intravenous injection of gadolinium chelates
- Patient affiliated to the social security system
- Patients who received oral and written information
Who cannot join
- Patient deprived of liberty as a result of a judicial or administrative decision.
- Patient under guardianship or curatorship.
- Any event preventing or prematurely interrupting the collection of assessment criteria would result in the premature exit of the subject.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospital of Edouard Herriot
Lyon, 69003
Olivier ROUVIERE, Professor
About this study
Official title: Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound ((Magnetic Resonance Imaging) Obtained in Vivo by the Koelis™ System
The study aims at quantifying the registration error obtained in routine patients in different parts of the prostate and for operators with different experience in order to assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.
Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate cancer will be prospectively offered to enter the study.
The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex, midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the prostate will be obtained at the end of the placement. As per our routine procedure, patients will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed by operators of varying experience using the Koelis system. The fiducials (visible on MR and ultrasound images) will be used to quantify the registration error.
- Conditions
- Cancer of the Prostate
- Keywords
- ultrasound, Koelis system, MRI, gold grain
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the overall registration obtained by the Koelis™ system
The fusion will be performed retrospectively without interfering with patient management. This fusion is an off-line analysis that will be performed within one month of the images acquisition. Each of the four operators will perform a US/MR fusion for all patients and will be blinded to the fusions performed by the others. The results will be presented when all operators have finished the fusions in all patients.
The overall registration error (TRE3D, defined as the Euclidean distance between the US marker and the MR marker after fusion) will be calculated based on the 3D coordinates of the fiducials on MR and ultrasound images.
Measured: 1 month
Secondary outcomes (2)
Influence on TRE3D of the position of the fiducials (apex, midgland and base)
The fusion will be performed retrospectively without interfering with patient management. This fusion is an off-line analysis that will be performed within one month of the images acquisition. Each of the four operators will perform a US/MR fusion for all patients and will be blinded to the fusions performed by the others. The results will be presented when all operators have finished the fusions in all patients.
The distribution of TRE3D for the markers at the apex, midgalnd and base will be compared
Measured: 1 month
Influence on TRE3D of the experience of the fusion operators
The fusion will be performed retrospectively without interfering with patient management. This fusion is an off-line analysis that will be performed within one month of the images acquisition. Each of the four operators will perform a US/MR fusion for all patients and will be blinded to the fusions performed by the others. The results will be presented when all operators have finished the fusions in all patients.
The distribution of TRE3D for the four operators will be compared
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the ProstateStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879851
- Sponsor's protocol ID
- 69HCL16_0422
- Acronym
- EFEL
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound ((Magnetic Resonance Imaging) Obtained in Vivo by the Koelis™ System
- ClinicalTrials.gov ID
- NCT02879851
- Acronym / sponsor ID
- EFEL / 69HCL16_0422
- Conditions
- Cancer of the Prostate
- Keywords
- ultrasound, Koelis system, MRI, gold grain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 26 Aug 2016 (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 study aims at quantifying the registration error obtained in routine patients in different parts of the prostate and for operators with different experience in order to assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.
Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate cancer will be prospectively offered to enter the study.
The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex, midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the prostate will be obtained at the end of the placement. As per our routine procedure, patients will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed by operators of varying experience using the Koelis system. The fiducials (visible on MR and ultrasound images) will be used to quantify the registration error.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prostate cancer referred for placement of intraprostatic fiducials before prostate radiotherapy
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Patient requiring placement of intraprostatic fiducials
- No contra-indication for fiducials placement
- No contra -indication to MRI
- No contra -indication for intravenous injection of gadolinium chelates
Key exclusion criteria (3 listed)
- Patient deprived of liberty as a result of a judicial or administrative decision.
- Patient under guardianship or curatorship.
- Any event preventing or prematurely interrupting the collection of assessment criteria would result in the premature exit of the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of the overall registration obtained by the Koelis™ system
Time frame: 1 month
The fusion will be performed retrospectively without interfering with patient management. This fusion is an off-line analysis that will be performed within one month of the images acquisition. Each of the four operators will perform a US/MR fusion for all patients and will be blinded to the fusions performed by the others. The results will be presented when all operators have finished the fusions in all patients. The overall registration error (TRE3D, defined as the Euclidean distance between the US marker and the MR marker after fusion) will be calculated based on the 3D coordinates of the fiducials on MR and ultrasound images.
2 secondary outcomes
Influence on TRE3D of the position of the fiducials (apex, midgland and base)
Time frame: 1 month
Influence on TRE3D of the experience of the fusion operators
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
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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.
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 Cancer of the Prostate, run by Hospices Civils de Lyon 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier ROUVIERE, Professor (+334 72 11 09 50, olivier.rouviere@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the overall registration obtained by the Koelis™ system (time frame: 1 month). 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 26 Aug 2016.