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

NCT03852836 | Terminated

• 1 other identifier: 18-004
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallstone; Cholangitis; Cholangiocarcinoma; Pancreatitis; Pancreatic Ductal Adenocarcinoma

Keywords

Cholangiopancreatography by MRI; Compressed Sensing

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day: from the consent signature to the end of the exam

Secondary Outcomes (4)

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

  1 day: from the consent signature to the end of the exam

• Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 3T MRI scanner

  1 day: from the consent signature to the end of the exam

• Comparison of the sequences between 1.5T and 3T MRI scanners evaluated with the Likert score

  1 day: from the consent signature to the end of the exam

• 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

  1 day: from the consent signature to the end of the exam

Study Arms (2)

1.5T magnetic field

OTHER

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.

Other: ultra-rapid acquisition of bile ducts images

3T magnetic field

OTHER

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.

Other: ultra-rapid acquisition of bile ducts images

Interventions

ultra-rapid acquisition of bile ducts images OTHER

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.

1.5T magnetic field; 3T magnetic field

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Radiologie et d'Echographie, NHC Strasbourg

Strasbourg, 67 091, France

Location

Related Publications (3)

• 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.

  PMID: 27150328 BACKGROUND

• 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.

  PMID: 28448309 BACKGROUND

• 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.

  PMID: 26982678 BACKGROUND

MeSH Terms

Conditions

Gallstones; Cholangitis; Cholangiocarcinoma; Pancreatitis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Bile Duct Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Diseases

Study Officials

• Vanina Faucher, MD

  Service de Radiologie et d'Echographie, NHC Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: February 26, 2019
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)