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Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis (TractoCA)

Primary Purpose

Inflammatory Bowel Disease, Neoplastic Pathology

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI with DTI sequence
Sponsored by
IHU Strasbourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Disease focused on measuring Anatomy, Fiber tractography, Pelvic floor, Diffusion Tensor Imaging (DTI), Magnetic Resonance Imaging (MRI)

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 able to receive and understand information related to the study and give written informed consent
  3. Patient affiliated to the French social security system
  4. Patient undergoing a pelvic MRI examination whose result at the end of the T2 sequences in the 3 section planes shows the absence of pathology or a distant pathology that does not affect the pelvic sphincters OR Patient undergoing a pelvic surgery including fistula treatment, abscess treatment, sigmoid mucosectomy or rectal mucosectomy

Exclusion Criteria:

  1. Patient who previously had a therapeutic procedure affecting the sphincters
  2. Patient with hip prostheses
  3. 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
  4. Patient presenting, in the judgment of the investigator, an illness that may prevent participation in the procedures provided by the study
  5. Pregnant or lactating patient
  6. Patient in exclusion period (determined by a previous or a current study)
  7. Patient under guardianship or trusteeship
  8. Patient under the protection of justice

Sites / Locations

  • Service de Radiologie et d'Echographie, NHC Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pelvic MRI

Pelvic surgery

Arm Description

This arm involves patients undergoing a pelvic MRI. At the end of the planned sequence, but before any contrast agent injection: Acquisition of a an additional anatomical T2 SPACE sequence Acquisition of a tractography Diffusion Tensor Imaging (DTI) sequence All acquisitions will be done in an acceptable duration (less than 45 minutes)

This arm involves patients undergoing a pelvic surgery and coming for a postoperative MRI. An additional MRI is performed before the surgery and additional sequences are added to the planned postoperative MRI, at the end of the planned sequence, but before any contrast agent injection: Acquisition of a an additional anatomical T2 SPACE sequence Acquisition of a tractography Diffusion Tensor Imaging (DTI) sequence All acquisitions will be done in an acceptable duration (less than 45 minutes)

Outcomes

Primary Outcome Measures

The ability of MRI tractography to visualize the muscular architecture of pelvic sphincters evaluated with a Likert score.
This criterion is quantitative and is evaluated on the basis of a Likert score varying between 1 and 5 which will be attributed to each sphincter. Score 1 = no reconstruction: sphincter not visualised Score 2 = insufficient reconstruction: the fiber architecture is incoherent and / or few fibers are rebuilt Score 3 = acceptable reconstruction: the reconstructed fibers provide an overview of sphincter architecture despite the presence of incoherent or missing fibers Score 4 = satisfactory reconstruction: the sphincter is generally well reconstructed, little incoherence and missing fibers Score 5 = excellent reconstruction: the appearance of the sphincter reflects the expected anatomy, without missing or inconsistent fibers.

Secondary Outcome Measures

Evaluation of the sphincter orientation based on a color gradient.
The reconstruction of the muscle fibers in tractography is done according to a precise color code (blue if orientation up-down, green for front-back, and red for left-right). The analysis will be done on the color gradient.
Thickness of the sphincters evaluated in millimetres
The thickness of the sphincters will be measured in millimetres
Fractional Anisotropy (FA) Values in Sphincter Fibres
Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions.
Apparent Diffusion Coefficient (ADC) Values in Sphincter Fibres
Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) expressed in units of square millimetres per second (mm2/s).

Full Information

First Posted
March 4, 2019
Last Updated
March 28, 2022
Sponsor
IHU Strasbourg
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1. Study Identification

Unique Protocol Identification Number
NCT03881436
Brief Title
Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis
Acronym
TractoCA
Official Title
Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
August 12, 2021 (Actual)
Study Completion Date
August 12, 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
Urinary and faecal incontinences generally come from a dysfunction of the pelvic floor muscles, and more particularly the sphincters. Among other causes, they may be related to accidental trauma, obstetric or iatrogenic. On this last point, the incidence of surgical interventions on the bladder collar and on the anal canal on the prevalence of incontinences can be underlined. MRI tractography could be an interesting tool to visualize in 3D the structure of pelvic sphincters and their lesions. It may thereby establish the link with observed dysfunctions, thus potentially providing a complement to the urological and proctographic examinations already carried out. The objective of this study is, first, to define the sensitivity of the MRI tractography for the visualization of the pelvic sphincters architecture regardless of the gender. In a second time, it will give a description of normal and abnormal (pathological cases) tractography, as well as a descriptive post-surgery. The other interest of this study is the assessment of the information provided by pelvic sphincters tractography on a panel of various and frequently encountered situations in clinical routine at the IHU.
Detailed Description
Urinary and faecal incontinences are psychologically difficult to live with. These disorders generally come from a dysfunction of the pelvic floor muscles, and more particularly the sphincters: the urethral sphincter at the level of the urinary tract, and the anal sphincter at the level of the defecatory apparatus. The causes leading to urinary or faecal incontinence are multiple. They may be related to age or weight, or to accidental trauma, obstetric or iatrogenic. On this last point, the incidence of surgical interventions on the bladder collar and on the anal canal on the prevalence of incontinences can be underlined. In case of dysfunction, the sphincters can be scanned by imaging, including MRI, to assess the thickness or detect the presence of scars. The current MRI examinations in clinical routine are not capable to characterize the complex architecture of these muscles. MRI tractography, mainly known as a tool for visualisation and characterisation of white matter fibers in the brain via the acquisition of DTI (Diffusion Tensor Imaging) sequences, could be an interesting tool to visualize in 3D the structure of pelvic sphincters and their lesions. It may thereby establish the link with observed dysfunctions, thus potentially providing a complement to the urological and proctographic examinations already carried out. Some studies have already shown that MRI is an ideal method for visualizing pelvic floor muscle fibers in women. As far as it is known, there are no studies in the literature on pelvic sphincter tractography. The objective is, first, to define from this initial study the sensitivity of the method for the visualization of the pelvic sphincters architecture regardless of the gender. In a second time, it will give a description of normal and abnormal (pathological cases) tractography, as well as a descriptive post-surgery. The results found in each of these situations can be compared in order to evaluate the sensitivity and contribution of MRI tractography for the diagnosis of pelvic sphincter dysfunctions and their management, as well as to evaluate the impact of surgery. The other interest of this study is the inclusion of both patients consulting for a simple diagnosis and those coming for a pre- and post-operative examination. This will allow the assessment of the information provided by pelvic sphincters tractography on a panel of various and frequently encountered situations in clinical routine at the IHU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Neoplastic Pathology
Keywords
Anatomy, Fiber tractography, Pelvic floor, Diffusion Tensor Imaging (DTI), Magnetic Resonance Imaging (MRI)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pelvic MRI
Arm Type
Experimental
Arm Description
This arm involves patients undergoing a pelvic MRI. At the end of the planned sequence, but before any contrast agent injection: Acquisition of a an additional anatomical T2 SPACE sequence Acquisition of a tractography Diffusion Tensor Imaging (DTI) sequence All acquisitions will be done in an acceptable duration (less than 45 minutes)
Arm Title
Pelvic surgery
Arm Type
Experimental
Arm Description
This arm involves patients undergoing a pelvic surgery and coming for a postoperative MRI. An additional MRI is performed before the surgery and additional sequences are added to the planned postoperative MRI, at the end of the planned sequence, but before any contrast agent injection: Acquisition of a an additional anatomical T2 SPACE sequence Acquisition of a tractography Diffusion Tensor Imaging (DTI) sequence All acquisitions will be done in an acceptable duration (less than 45 minutes)
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI with DTI sequence
Intervention Description
At the end of the planned sequence, but before any contrast agent injection: Acquisition of a an additional anatomical T2 SPACE sequence Acquisition of a tractography DTI sequence
Primary Outcome Measure Information:
Title
The ability of MRI tractography to visualize the muscular architecture of pelvic sphincters evaluated with a Likert score.
Description
This criterion is quantitative and is evaluated on the basis of a Likert score varying between 1 and 5 which will be attributed to each sphincter. Score 1 = no reconstruction: sphincter not visualised Score 2 = insufficient reconstruction: the fiber architecture is incoherent and / or few fibers are rebuilt Score 3 = acceptable reconstruction: the reconstructed fibers provide an overview of sphincter architecture despite the presence of incoherent or missing fibers Score 4 = satisfactory reconstruction: the sphincter is generally well reconstructed, little incoherence and missing fibers Score 5 = excellent reconstruction: the appearance of the sphincter reflects the expected anatomy, without missing or inconsistent fibers.
Time Frame
1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Secondary Outcome Measure Information:
Title
Evaluation of the sphincter orientation based on a color gradient.
Description
The reconstruction of the muscle fibers in tractography is done according to a precise color code (blue if orientation up-down, green for front-back, and red for left-right). The analysis will be done on the color gradient.
Time Frame
1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Title
Thickness of the sphincters evaluated in millimetres
Description
The thickness of the sphincters will be measured in millimetres
Time Frame
1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Title
Fractional Anisotropy (FA) Values in Sphincter Fibres
Description
Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions.
Time Frame
1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Title
Apparent Diffusion Coefficient (ADC) Values in Sphincter Fibres
Description
Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) expressed in units of square millimetres per second (mm2/s).
Time Frame
1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group

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 able to receive and understand information related to the study and give written informed consent Patient affiliated to the French social security system Patient undergoing a pelvic MRI examination whose result at the end of the T2 sequences in the 3 section planes shows the absence of pathology or a distant pathology that does not affect the pelvic sphincters OR Patient undergoing a pelvic surgery including fistula treatment, abscess treatment, sigmoid mucosectomy or rectal mucosectomy Exclusion Criteria: Patient who previously had a therapeutic procedure affecting the sphincters Patient with hip prostheses 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 Pregnant or lactating patient Patient in exclusion period (determined by a previous or a current study) Patient under guardianship or trusteeship Patient under the protection of justice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine ROY, 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
21197534
Citation
Zijta FM, Froeling M, van der Paardt MP, Lakeman MM, Bipat S, van Swijndregt AD, Strijkers GJ, Nederveen AJ, Stoker J. Feasibility of diffusion tensor imaging (DTI) with fibre tractography of the normal female pelvic floor. Eur Radiol. 2011 Jun;21(6):1243-9. doi: 10.1007/s00330-010-2044-8. Epub 2011 Jan 1.
Results Reference
background
PubMed Identifier
22797954
Citation
Zijta FM, Lakeman MM, Froeling M, van der Paardt MP, Borstlap CS, Bipat S, Montauban van Swijndregt AD, Strijkers GJ, Roovers JP, Nederveen AJ, Stoker J. Evaluation of the female pelvic floor in pelvic organ prolapse using 3.0-Tesla diffusion tensor imaging and fibre tractography. Eur Radiol. 2012 Dec;22(12):2806-13. doi: 10.1007/s00330-012-2548-5. Epub 2012 Jul 14.
Results Reference
background
PubMed Identifier
22757638
Citation
Rousset P, Delmas V, Buy JN, Rahmouni A, Vadrot D, Deux JF. In vivo visualization of the levator ani muscle subdivisions using MR fiber tractography with diffusion tensor imaging. J Anat. 2012 Sep;221(3):221-8. doi: 10.1111/j.1469-7580.2012.01538.x. Epub 2012 Jul 4.
Results Reference
background

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Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis

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