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

Primary Purpose

Gallstone, Cholangitis, Cholangiocarcinoma

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultra-rapid acquisition of bile ducts images
Sponsored by
IHU Strasbourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gallstone focused on measuring Cholangiopancreatography by MRI, Compressed Sensing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Service de Radiologie et d'Echographie, NHC Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1.5T magnetic field

3T magnetic field

Arm 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.

For each patient who undergo a 3T 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.

Outcomes

Primary Outcome Measures

Global quality of the images evaluated with a Likert score
The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.

Secondary Outcome Measures

Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 1.5T MRI scanner
The sequences will be compared in pairs based on the overall image quality to determine, where appropriate, the sequence providing the best performance. The global quality of the images will be evaluated with a Likert score as described in the primary outcome measure. The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.
Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 3T MRI scanner
The sequences will be compared in pairs based on the overall image quality to determine, where appropriate, the sequence providing the best performance. The global quality of the images will be evaluated with a Likert score as described in the primary outcome measure. The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.
Comparison of the sequences between 1.5T and 3T MRI scanners evaluated with the Likert score
Comparison of the sequences between 1.5T and 3T MRI scanners using the Likert score in order to determine the influence of the magnetic field on the global quality of the images. The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.
Performance of each sequence in the visualization of the pathology and / or an anatomical variant in the 1.5T magnetic field group, evaluated in percentage
The performance is evaluated as the number of well-diagnosed patients out of the total number of cases seen at surgery in the 1.5T magnetic field group

Full Information

First Posted
February 21, 2019
Last Updated
March 28, 2022
Sponsor
IHU Strasbourg
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1. Study Identification

Unique Protocol Identification Number
NCT03852836
Brief Title
Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images
Acronym
BiliFast
Official Title
Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID Pandemy - recruitment issue
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IHU Strasbourg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone, Cholangitis, Cholangiocarcinoma, Pancreatitis, Pancreatic Ductal Adenocarcinoma
Keywords
Cholangiopancreatography by MRI, Compressed Sensing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.5T magnetic field
Arm Type
Other
Arm 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.
Arm Title
3T magnetic field
Arm Type
Other
Arm Description
For each patient who undergo a 3T 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.
Intervention Type
Other
Intervention Name(s)
ultra-rapid acquisition of bile ducts images
Intervention Description
On top of the conventional SPACE sequence, 2 supplementary sequences will be performed with the ultra-rapid sequence (sequence CS-SPACE) either acquired in apnoea or synchronized with the breath.
Primary Outcome Measure Information:
Title
Global quality of the images evaluated with a Likert score
Description
The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.
Time Frame
1 day: from the consent signature to the end of the exam
Secondary Outcome Measure Information:
Title
Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 1.5T MRI scanner
Description
The sequences will be compared in pairs based on the overall image quality to determine, where appropriate, the sequence providing the best performance. The global quality of the images will be evaluated with a Likert score as described in the primary outcome measure. The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.
Time Frame
1 day: from the consent signature to the end of the exam
Title
Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 3T MRI scanner
Description
The sequences will be compared in pairs based on the overall image quality to determine, where appropriate, the sequence providing the best performance. The global quality of the images will be evaluated with a Likert score as described in the primary outcome measure. The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.
Time Frame
1 day: from the consent signature to the end of the exam
Title
Comparison of the sequences between 1.5T and 3T MRI scanners evaluated with the Likert score
Description
Comparison of the sequences between 1.5T and 3T MRI scanners using the Likert score in order to determine the influence of the magnetic field on the global quality of the images. The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.
Time Frame
1 day: from the consent signature to the end of the exam
Title
Performance of each sequence in the visualization of the pathology and / or an anatomical variant in the 1.5T magnetic field group, evaluated in percentage
Description
The performance is evaluated as the number of well-diagnosed patients out of the total number of cases seen at surgery in the 1.5T magnetic field group
Time Frame
1 day: from the consent signature to the end of the exam

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female over 18 years old Patient for whom MRI is required for the diagnosis or follow-up of a pathology Patient able to receive and understand information related to the study and give written informed consent Patient affiliated to the French social security system Exclusion Criteria: 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 Patient presenting, in the judgment of the investigator, an illness that may prevent participation in the procedures provided by the study Patient who has been operated urgently Pregnant or lactating patient Patient in exclusion period (determined by a previous or a current study) Patient under the protection of justice Patient under guardianship or trusteeship Patient subject to a legal protection measure or out of state to express their consent 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanina Faucher, MD
Organizational Affiliation
Service de Radiologie et d'Echographie, NHC Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Radiologie et d'Echographie, NHC Strasbourg
City
Strasbourg
ZIP/Postal Code
67 091
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27150328
Citation
Bates DD, LeBedis CA, Soto JA, Gupta A. Use of Magnetic Resonance in Pancreaticobiliary Emergencies. Magn Reson Imaging Clin N Am. 2016 May;24(2):433-48. doi: 10.1016/j.mric.2015.11.010. Epub 2016 Feb 22.
Results Reference
background
PubMed Identifier
28448309
Citation
Yoon JH, Lee SM, Kang HJ, Weiland E, Raithel E, Son Y, Kiefer B, Lee JM. Clinical Feasibility of 3-Dimensional Magnetic Resonance Cholangiopancreatography Using Compressed Sensing: Comparison of Image Quality and Diagnostic Performance. Invest Radiol. 2017 Oct;52(10):612-619. doi: 10.1097/RLI.0000000000000380.
Results Reference
background
PubMed Identifier
26982678
Citation
Chandarana H, Doshi AM, Shanbhogue A, Babb JS, Bruno MT, Zhao T, Raithel E, Zenge MO, Li G, Otazo R. Three-dimensional MR Cholangiopancreatography in a Breath Hold with Sparsity-based Reconstruction of Highly Undersampled Data. Radiology. 2016 Aug;280(2):585-94. doi: 10.1148/radiol.2016151935. Epub 2016 Mar 16.
Results Reference
background

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

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