Inflammatory Bowel DiseaseTractoCANCT03881436
Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis
A study testing MRI with DTI sequence in people with Inflammatory Bowel Disease and Neoplastic Pathology, run by IHU Strasbourg at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Neoplastic Pathology
- What is being tested?
- MRI with DTI sequence
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 12 Aug 2019to 12 Aug 2021
- 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
- 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
Who cannot join
- 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 ...
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Radiologie et d'Echographie, NHC Strasbourg
Strasbourg, 67 091
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Disease, Neoplastic Pathology
- Being tested
- MRI with DTI sequence
- Keywords
- Anatomy, Fiber tractography, Pelvic floor, Diffusion Tensor Imaging (DTI), Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with DTI sequenceDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Pelvic MRI | Experimental | 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) Receives: Diagnostic Test: MRI with DTI sequence |
| Pelvic surgery | Experimental | 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) Receives: Diagnostic Test: MRI with DTI sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Secondary outcomes (4)
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.
Measured: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Thickness of the sphincters evaluated in millimetres
The thickness of the sphincters will be measured in millimetres
Measured: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
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.
Measured: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
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).
Measured: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start12 Aug 2019
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine ROY, MD, Principal investigator, Service de Radiologie et d'Echographie, NHC Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881436
- Sponsor's protocol ID
- 18-005
- Acronym
- TractoCA
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21197534Zijta 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.
PubMed 22797954Rousset 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.
PubMed 22757638
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis
- ClinicalTrials.gov ID
- NCT03881436
- Acronym / sponsor ID
- TractoCA / 18-005
- Conditions
- Inflammatory Bowel Disease, Neoplastic Pathology
- Keywords
- Anatomy, Fiber tractography, Pelvic floor, Diffusion Tensor Imaging (DTI), Magnetic Resonance Imaging (MRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 19 Mar 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic MRI | Experimental | Diagnostic Test: MRI with DTI sequenceThis 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) |
| Pelvic surgery | Experimental | Diagnostic Test: MRI with DTI sequenceThis 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Patient who previously had a therapeutic procedure affecting the sphincters
- Patient with hip prostheses
- Patient with contraindications to MRI:
- 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
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 |
|---|---|---|
| MRI with DTI sequenceAt 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 | Diagnostic test | Pelvic MRI, Pelvic surgery |
Primary outcome
The ability of MRI tractography to visualize the muscular architecture of pelvic sphincters evaluated with a Likert score.
Time frame: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
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.
4 secondary outcomes
Evaluation of the sphincter orientation based on a color gradient.
Time frame: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Thickness of the sphincters evaluated in millimetres
Time frame: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Fractional Anisotropy (FA) Values in Sphincter Fibres
Time frame: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Apparent Diffusion Coefficient (ADC) Values in Sphincter Fibres
Time frame: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 21197534Zijta 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.
- Background: PubMed 22797954Zijta 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.
- Background: PubMed 22757638Rousset 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.
- Individual participant dataSharing planned: No
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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.
Catherine ROY, MD principal investigator
Service de Radiologie et d'Echographie, NHC Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI with DTI sequence in people with Inflammatory Bowel Disease and Neoplastic Pathology, run by IHU Strasbourg 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 14 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: finished, as of the sponsor's last update on 29 Mar 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The ability of MRI tractography to visualize the muscular architecture of pelvic sphincters evaluated with a Likert score. (time frame: 1 day for the "Pelvic MRI" group - 2 months for the "Pelvic surgery" group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881436, which also lists 3 linked publications.
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 29 Mar 2022.