Liver BiopsyIFENCT02573545
Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case
A study testing Planning@IFE and Standard@IFE Software and MR Syngo (Numaris/4) software in people with Liver Biopsy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable: a facilitation of the planning stages of the procedure (route path, marking of the entry point… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Biopsy
- What is being tested?
- Planning@IFE and Standard@IFE Software and MR Syngo (Numaris/4) software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Oct 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years old
- Affiliated to a social security scheme
- Informed consent
- Patient with an indication of liver biopsy eligible for a biopsy under interventional MRI
Who cannot join
- Patient with a contraindication for MRI exam
- Patient with a contraindication for performing a biopsy
- Pregnancy
- Patient unable to receive and understand information about the study
- Patients under guardianship
- Patients under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable:
- a facilitation of the planning stages of the procedure (route path, marking of the entry point and alignment of the MRI cutaways on the planned path), resulting in a reduction in the duration of the planning stages,
- a facilitation of the real-time modification of MRI cutaways during the procedure, resulting in a reduction of the duration of the procedure
- Conditions
- Liver Biopsy
- Being tested
- Planning@IFE and Standard@IFE Software, MR Syngo (Numaris/4) software
- Keywords
- liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planning@IFE and Standard@IFE SoftwareDevice
MR Syngo (Numaris/4) softwareDevice
| Study group | Role | What they receive |
|---|---|---|
| Test group: with IFE | Experimental | Patients treated with IFE software Receives: Device: Planning@IFE and Standard@IFE Software |
| Test group: without IFE | Active comparator | Patients treated with Numaris 4 software Receives: Device: MR Syngo (Numaris/4) software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total duration of the intervention (planning and implementation)
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startJan 2013
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Difficulty recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver BiopsyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573545
- Sponsor's protocol ID
- 5261
- Acronym
- IFE
- Status last verified
- Oct 2015
- First submitted
- 1 Oct 2015
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Support Software in the Planning and Real-time Monitoring of the Insertion of Needles in Interventional Magnetic Resonance Imaging (MRI): Liver Biopsy Case
- ClinicalTrials.gov ID
- NCT02573545
- Acronym / sponsor ID
- IFE / 5261
- Conditions
- Liver Biopsy
- Keywords
- liver
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting patients
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 9 Oct 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.
To demonstrate that the use of Standard @IFE and Planning@IFE features of the IFE software, compared to the current method, when planning and inserting the needle under MRI monitoring in the context of liver biopsies enable:
- a facilitation of the planning stages of the procedure (route path, marking of the entry point and alignment of the MRI cutaways on the planned path), resulting in a reduction in the duration of the planning stages,
- a facilitation of the real-time modification of MRI cutaways during the procedure, resulting in a reduction of the duration of the procedure
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group: with IFE | Experimental | Device: Planning@IFE and Standard@IFE SoftwarePatients treated with IFE software |
| Test group: without IFE | Active comparator | Device: MR Syngo (Numaris/4) softwarePatients treated with Numaris 4 software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is at least 18 years old
- Affiliated to a social security scheme
- Informed consent
- Patient with an indication of liver biopsy eligible for a biopsy under interventional MRI
Key exclusion criteria (6 listed)
- Patient with a contraindication for MRI exam
- Patient with a contraindication for performing a biopsy
- Pregnancy
- Patient unable to receive and understand information about the study
- Patients under guardianship
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 |
|---|---|---|
| Planning@IFE and Standard@IFE Software | Device | Test group: with IFE |
| MR Syngo (Numaris/4) software | Device | Test group: without IFE |
Primary outcome
Total duration of the intervention (planning and implementation)
Time frame: up to 2 weeks
Results and safety
The study was stopped early (reason given: Difficulty recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
Related trials for Liver Biopsy
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Not yet recruitingObservational study
Comparison of Liver Biopsy Versus Fibroscan With CAP ( Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant
Non-invasive Donor Liver Assessment
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingObservational study
Liver Biopsy Following Gene Therapy For Hemophilia
Hemophilia A, Hemophilia B
RecruitingObservational study
Endohepatology-Based Reclassification of Treatment Indication in High-Risk MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planning@IFE and Standard@IFE Software and MR Syngo (Numaris/4) software in people with Liver Biopsy, run by University Hospital, Strasbourg, France 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 4 inclusion and 6 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 4 Dec 2019. 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: Difficulty recruiting patients). 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?
Total duration of the intervention (planning and implementation) (time frame: up to 2 weeks). 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 4 Dec 2019.