Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images

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Brief Title

Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images

Official Title

Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images

Brief Summary

      The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical Magnetic Resonance
      Imaging (MRI) scanners, one with a 3T (3 Teslas) magnetic field used for diagnosis, the other
      with a magnetic field of 1,5T (1,5 Teslas) used for the interventional (Pre / per /
      postoperative).

      The reference for the visualization of the biliary and pancreatic ducts is a relatively long
      sequence that needs a breathing-synchronized acquisition leading to artefacts on the images
      (blur effect).

      In order to reduce and/or standardize the acquisition time as well as to limit artefacts,
      accelerated sequences are developed. Such sequence is available in France recently in the
      form of WIP Siemens (Work In Progress: sequence in test phase at manufacturer to be marketed
      in the short or medium term on clinical machines). It incorporates a Compressed Sensing (CS)
      acquisition scheme allowing the acquisition of a 3D (3 dimensions) sequence similar to the
      usual sequence by drastically reducing the acquisition time, the sequence CS-SPACE. This
      sequence exists in two forms:

        -  An ultra-rapid sequence acquired in apnea

        -  An accelerated sequence but remaining synchronized with the breath. The study carried
           out here on a large number of patients, with two different magnetic fields, applied
           routinely for diagnosis or anticipation of surgery, could be used by the community of
           radiologists, hepatogastroenterologists and also digestive surgeons Hepatobiliary.
    

Detailed Description

      The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical MRIs, one with a 3T
      (Teslas) magnetic field used for diagnosis, the other with a magnetic field of 1,5T (Teslas)
      used for the interventional (Pre / per / postoperative).

      Cholangiopancreatography by MRI (or bili-MRI) accounts for about 25% of MRI examinations at
      the IHU and is used for the diagnosis of pathologies affecting the bile ducts (lithiasis
      pathology, cholangitis, tumoral pathology of the bile ducts) and the pancreas (search for a
      causal pathology to pancreatitis (calculus), ductal pathology, ductal study in tumor
      pathology). It can be done in preoperative context (cholecystectomy) for research of an
      associated calculus in the bile ducts, or for an anatomical analysis of the bile ducts
      (possible anatomical variants ...).

      The reference for the visualization of the biliary and pancreatic ducts is a very heavily
      weighted T2 3D SPACE sequence. A 3D volume is obtained in which they appear in white, and the
      projection of this volume makes it possible to visualize the entire tract. This sequence is
      relatively long and needs a breathing-synchronized acquisition. The time of acquisition is
      then very variable from one patient to another (4 to 8 minutes). This extended acquisition
      time in addition to the variability of rhythm and respiratory profile can lead to artefacts
      on the images (blur effect). These are the limits of the respiratory synchronization that
      triggers acquisition by referring to the position of the liver dome which is not perfectly
      reproducible from a breathing cycle to the other, potentially degrading the appearance of the
      bile ducts and the reliability of the diagnosis.

      A solution that makes it possible to reduce and / or standardize the acquisition time as well
      as to limit artefacts is to use an accelerated sequence. Such a sequence is available in
      France recently in the form of WIP Siemens (Work In Progress: sequence in test phase at
      manufacturer to be marketed in the short or medium term on clinical machines). It
      incorporates a Compressed Sensing (CS) acquisition scheme allowing the acquisition of a 3D
      sequence similar to the usual sequence by drastically reducing the acquisition time, the
      sequence CS-SPACE. This sequence exists in two forms:

        -  An ultra-rapid sequence acquired in apnea

        -  An accelerated sequence but remaining synchronized with the breath. This sequence has
           been shown to provide comparable, if not better, results to those obtained with the
           usual sequence in terms of image quality and visualization of structures, but these
           results were only obtained at 3T and for a reduced cohort of patients.

      A lot of work is done today in the field of MRI to reduce the time of sequence acquisition.
      Accelerated acquisition schemes like Compressed Sensing remain marginal but are set to become
      the norm in the long term. The use of the sequence CS-SPACE at the IHU therefore enters into
      this perspective of reducing examination times.

      The study carried out here on a large number of patients, with two different magnetic fields,
      applied routinely for diagnosis or anticipation of surgery, could be used by the community of
      radiologists, hepatogastroenterologists and also digestive surgeons Hepatobiliary.
    


Study Type

Interventional


Primary Outcome

Global quality of the images evaluated with a Likert score

Secondary Outcome

 Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 1.5T MRI scanner

Condition

Gallstone

Intervention

ultra-rapid acquisition of bile ducts images

Study Arms / Comparison Groups

 1.5T magnetic field
Description:  For each patient who undergo a 1.5T MRI, 3 sequences will be done: (i) a conventional SPACE sequence, (ii) an ultra-rapid sequence (sequence CS-SPACE) acquired in apnoea and (iii) an accelerated sequence (sequence CS-SPACE) but remaining synchronized with the breath.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

February 26, 2019

Completion Date

February 2021

Primary Completion Date

February 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female over 18 years old

          2. Patient for whom MRI is required for the diagnosis or follow-up of a pathology

          3. Patient able to receive and understand information related to the study and give
             written informed consent

          4. Patient affiliated to the French social security system

        Exclusion Criteria:

          1. Patient with contraindications to MRI:

               -  pacemaker or automatic defibrillator, pump

               -  implanted

               -  auditory, anal, painkiller neurostimulator, etc ...

               -  ferromagnetic bodies in soft tissues, body

               -  intraocular foreigners, cerebrovascular clips

               -  claustrophobia

          2. Patient presenting, in the judgment of the investigator, an illness that may prevent
             participation in the procedures provided by the study

          3. Patient who has been operated urgently

          4. Pregnant or lactating patient

          5. Patient in exclusion period (determined by a previous or a current study)

          6. Patient under the protection of justice

          7. Patient under guardianship or trusteeship

          8. Patient subject to a legal protection measure or out of state to express their consent

          9. Patient in a situation of social fragility

        A patient may be excluded at the end of the examination if at least one of the three
        sequences of bili-MRI could not be obtained (apnea impossible, image reconstruction
        problem).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Vanina Faucher, MD, +33(0)390413608, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03852836

Organization ID

18-004


Responsible Party

Sponsor

Study Sponsor

IHU Strasbourg


Study Sponsor

Vanina Faucher, MD, Principal Investigator, Service de Radiologie et d'Echographie, NHC Strasbourg


Verification Date

March 2019