Healthy VolunteersNeuro-TractoNCT02582346
Assessment of Magnetic Resonance Imaging Neurography and Tractography for Preoperative Mapping of Pelvic Nerves
A study testing MRI acquisition - no contrast agent in people with Healthy Volunteers, run by IHU Strasbourg at 1 site in France.
Trial summary
This project aims at assessing two MRI acquisition methods, neurography and tractography, for the visualization of pelvic nerves. The goal is to optimize both methods and to test them on a pool of volunteers to assess if nerves can be delineated, so as to provide an individualized mapping of nerves to surgeons before… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MRI acquisition - no contrast agent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Mar 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers, male or female, from 18 years old
- Volunteers able to understand the study and to provide informed consent
- Volunteers affiliated to the French social security system
Who cannot join
- Volunteer with contraindications to MRI (implanted device like pace-maker or neurostimulator, ferromagnetic materials, claustrophobia or obesity)
- Volunteer that already underwent pelvic surgery
- Volunteer pregnant or breastfeeding
- Volunteer unable to provide informed consent
- Volunteer refusing to be informed of any anomaly during an exam
- Volunteer that already received more than 4500€ of allowance for biomedical testing
Show all 10Show fewer
- Volunteer in exclusion period (determined by a previous study or in progress)
- Volunteer having forfeited their freedom of an administrative or legal obligation
- Volunteer under guardianship
- Volunteer carrying a multiresistant bacteria
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS
Strasbourg, 67000
About this study
This project aims at assessing two MRI acquisition methods, neurography and tractography, for the visualization of pelvic nerves. The goal is to optimize both methods and to test them on a pool of volunteers to assess if nerves can be delineated, so as to provide an individualized mapping of nerves to surgeons before an intervention and avoid postoperative complications.
Read the detailed description
Nerves of the autonomic nervous system are frequently damaged during pelvic surgery, and those injuries may lead to postoperative complications like incontinence or impotence. This study aims at developing an imaging protocol providing images where nerves can be visualized and segmented. A simple preoperative MRI exam might yield an individualized mapping of pelvic nerves that would be combined to augmented reality, thereby providing a valuable support to guide surgeons during an intervention by indicating location of the nerves that have to be preserved.
Up to now, investigations have been carried out with a 1.5 Tesla (1.5T) MRI system on an animal model (pig). MRI is non irradiant and non invasive imaging modality that proved to be a valuable method to visualize small structures like nerves. Investigations focused on MRI neurography, an anatomical imaging method highlighting nerves, and MRI tractography, a diffusion-tensor-based imaging method allowing reconstruction of nervous fibers. However, the swine model is not ideal due to major differences with human, more particularly the fact that the human pelvis contains a lot of fat unlike the swine pelvis, which is an interesting feature as there is a good contrast between fat and tissue in MRI. Therefore, it is important to perform new investigations in healthy volunteers to refine and assess the MRI acquisitions. Those investigations will be performed with a 3Tesla (3T) system from the same manufacturer, providing the same sequences but a higher field strength which should offer higher signal. There will be no injection of contrast agent. The protocol will use standard sequences from the manufacturer with parameters adjusted for the purposes of the study. The image quality will be scored on a 5-point Likert scale (0 = no possible delineation to 4=nerves are entirely visible).
- Conditions
- Healthy Volunteers
- Being tested
- MRI acquisition - no contrast agent
- Keywords
- MRI, Neurography, Tractography, Pelvic nerves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI acquisition - no contrast agentProcedure or surgery
No surgery. Volunteers will have an MRI with a 3T clinical system. Installation will be performed according to standard protocols. Different neurography and tractography sequences will be acquired in order to get different contrasts.
| Study group | Role | What they receive |
|---|---|---|
| MRI acquisition - no contrast agent | Experimental | Volunteers will have an MRI with a 3T clinical system. Installation will be performed according to standard protocols. Different neurography and tractography sequences will be acquired in order to get different contrasts. Receives: Procedure: MRI acquisition - no contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of image quality to delineate and identify nerves
The assessment of image quality to delineate and identify nerves will be scored on a five-point Likert scale by the operator, and independently reviewed by a radiologist.
Measured: At the time of exam
Secondary outcomes (3)
Image quality at 1.5T and 3T by comparison of signal-to-noise ratios
Assessment of signal-to-noise ratios to compare 1.5T and 3T fields.
Measured: At the time of exam
Comparative evaluation score for neurography and tractography methods
Neurography and tractography methods will be scored on a five-point Lickert scale.
Measured: Through study completion, an average of 1 year
Acquisition time for neurography and tractography methods
Required acquisition time for neurography and tractography methods will be compared if evaluation scores are equivalent.
Measured: At the time of exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Grucker, MD, PhD, Principal investigator, Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582346
- Sponsor's protocol ID
- 15-004
- Acronym
- Neuro-Tracto
- Status last verified
- Mar 2018
- First submitted
- 16 Oct 2015
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Porter GA, Soskolne CL, Yakimets WW, Newman SC. Surgeon-related factors and outcome in rectal cancer. Ann Surg. 1998 Feb;227(2):157-67. doi: 10.1097/00000658-199802000-00001.
PubMed 9488510Baader B, Herrmann M. Topography of the pelvic autonomic nervous system and its potential impact on surgical intervention in the pelvis. Clin Anat. 2003 Mar;16(2):119-30. doi: 10.1002/ca.10105.
PubMed 12589666Lange MM, Marijnen CA, Maas CP, Putter H, Rutten HJ, Stiggelbout AM, Meershoek-Klein Kranenbarg E, van de Velde CJ; Cooperative clinical investigators of the Dutch. Risk factors for sexual dysfunction after rectal cancer treatment. Eur J Cancer. 2009 Jun;45(9):1578-88. doi: 10.1016/j.ejca.2008.12.014. Epub 2009 Jan 13.
PubMed 19147343Lim KS, Tan CH. Diffusion-weighted MRI of adult male pelvic cancers. Clin Radiol. 2012 Sep;67(9):899-908. doi: 10.1016/j.crad.2012.01.016. Epub 2012 Apr 11.
PubMed 22498730Shihab OC, Heald RJ, Rullier E, Brown G, Holm T, Quirke P, Moran BJ. Defining the surgical planes on MRI improves surgery for cancer of the low rectum. Lancet Oncol. 2009 Dec;10(12):1207-11. doi: 10.1016/S1470-2045(09)70084-1.
PubMed 19959077Filler AG, Howe FA, Hayes CE, Kliot M, Winn HR, Bell BA, Griffiths JR, Tsuruda JS. Magnetic resonance neurography. Lancet. 1993 Mar 13;341(8846):659-61. doi: 10.1016/0140-6736(93)90422-d.
PubMed 8095572Takahara T, Hendrikse J, Yamashita T, Mali WP, Kwee TC, Imai Y, Luijten PR. Diffusion-weighted MR neurography of the brachial plexus: feasibility study. Radiology. 2008 Nov;249(2):653-60. doi: 10.1148/radiol.2492071826. Epub 2008 Sep 16.
PubMed 18796657van der Jagt PK, Dik P, Froeling M, Kwee TC, Nievelstein RA, ten Haken B, Leemans A. Architectural configuration and microstructural properties of the sacral plexus: a diffusion tensor MRI and fiber tractography study. Neuroimage. 2012 Sep;62(3):1792-9. doi: 10.1016/j.neuroimage.2012.06.001. Epub 2012 Jun 13.
PubMed 22705377Bertrand MM, Macri F, Mazars R, Droupy S, Beregi JP, Prudhomme M. MRI-based 3D pelvic autonomous innervation: a first step towards image-guided pelvic surgery. Eur Radiol. 2014 Aug;24(8):1989-97. doi: 10.1007/s00330-014-3211-0. Epub 2014 May 17.
PubMed 24838739Soler L, Nicolau S, Pessaux P, Mutter D, Marescaux J. Real-time 3D image reconstruction guidance in liver resection surgery. Hepatobiliary Surg Nutr. 2014 Apr;3(2):73-81. doi: 10.3978/j.issn.2304-3881.2014.02.03.
PubMed 24812598Chang KJ, Kamel IR, Macura KJ, Bluemke DA. 3.0-T MR imaging of the abdomen: comparison with 1.5 T. Radiographics. 2008 Nov-Dec;28(7):1983-98. doi: 10.1148/rg.287075154.
PubMed 19001653Wijsmuller AR, Giraudeau C, Leroy J, Kleinrensink GJ, Rociu E, Romagnolo LG, Melani AGF, Agnus V, Diana M, Soler L, Dallemagne B, Marescaux J, Mutter D. A step towards stereotactic navigation during pelvic surgery: 3D nerve topography. Surg Endosc. 2018 Aug;32(8):3582-3591. doi: 10.1007/s00464-018-6086-3. Epub 2018 Feb 12.
PubMed 29435745
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Magnetic Resonance Imaging Neurography and Tractography for Preoperative Mapping of Pelvic Nerves
- ClinicalTrials.gov ID
- NCT02582346
- Acronym / sponsor ID
- Neuro-Tracto / 15-004
- Conditions
- Healthy Volunteers
- Keywords
- MRI, Neurography, Tractography, Pelvic nerves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Oct 2015 (estimated)
- 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.
This project aims at assessing two MRI acquisition methods, neurography and tractography, for the visualization of pelvic nerves. The goal is to optimize both methods and to test them on a pool of volunteers to assess if nerves can be delineated, so as to provide an individualized mapping of nerves to surgeons before an intervention and avoid postoperative complications.
Detailed description
Nerves of the autonomic nervous system are frequently damaged during pelvic surgery, and those injuries may lead to postoperative complications like incontinence or impotence. This study aims at developing an imaging protocol providing images where nerves can be visualized and segmented. A simple preoperative MRI exam might yield an individualized mapping of pelvic nerves that would be combined to augmented reality, thereby providing a valuable support to guide surgeons during an intervention by indicating location of the nerves that have to be preserved.
Up to now, investigations have been carried out with a 1.5 Tesla (1.5T) MRI system on an animal model (pig). MRI is non irradiant and non invasive imaging modality that proved to be a valuable method to visualize small structures like nerves. Investigations focused on MRI neurography, an anatomical imaging method highlighting nerves, and MRI tractography, a diffusion-tensor-based imaging method allowing reconstruction of nervous fibers. However, the swine model is not ideal due to major differences with human, more particularly the fact that the human pelvis contains a lot of fat unlike the swine pelvis, which is an interesting feature as there is a good contrast between fat and tissue in MRI. Therefore, it is important to perform new investigations in healthy volunteers to refine and assess the MRI acquisitions. Those investigations will be performed with a 3Tesla (3T) system from the same manufacturer, providing the same sequences but a higher field strength which should offer higher signal. There will be no injection of contrast agent. The protocol will use standard sequences from the manufacturer with parameters adjusted for the purposes of the study. The image quality will be scored on a 5-point Likert scale (0 = no possible delineation to 4=nerves are entirely visible).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI acquisition - no contrast agent | Experimental | Procedure: MRI acquisition - no contrast agentVolunteers will have an MRI with a 3T clinical system. Installation will be performed according to standard protocols. Different neurography and tractography sequences will be acquired in order to get different contrasts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteers, male or female, from 18 years old
- Volunteers able to understand the study and to provide informed consent
- Volunteers affiliated to the French social security system
Key exclusion criteria (10 listed)
- Volunteer with contraindications to MRI (implanted device like pace-maker or neurostimulator, ferromagnetic materials, claustrophobia or obesity)
- Volunteer that already underwent pelvic surgery
- Volunteer pregnant or breastfeeding
- Volunteer unable to provide informed consent
- Volunteer refusing to be informed of any anomaly during an exam
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 acquisition - no contrast agentNo surgery. Volunteers will have an MRI with a 3T clinical system. Installation will be performed according to standard protocols. Different neurography and tractography sequences will be acquired in order to get different contrasts. | Procedure or surgery | MRI acquisition - no contrast agent |
Primary outcome
Assessment of image quality to delineate and identify nerves
Time frame: At the time of exam
The assessment of image quality to delineate and identify nerves will be scored on a five-point Likert scale by the operator, and independently reviewed by a radiologist.
3 secondary outcomes
Image quality at 1.5T and 3T by comparison of signal-to-noise ratios
Time frame: At the time of exam
Comparative evaluation score for neurography and tractography methods
Time frame: Through study completion, an average of 1 year
Acquisition time for neurography and tractography methods
Time frame: At the time of exam
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 14 Mar 2018.
- Background: PubMed 9488510Porter GA, Soskolne CL, Yakimets WW, Newman SC. Surgeon-related factors and outcome in rectal cancer. Ann Surg. 1998 Feb;227(2):157-67. doi: 10.1097/00000658-199802000-00001.
- Background: PubMed 12589666Baader B, Herrmann M. Topography of the pelvic autonomic nervous system and its potential impact on surgical intervention in the pelvis. Clin Anat. 2003 Mar;16(2):119-30. doi: 10.1002/ca.10105.
- Background: PubMed 19147343Lange MM, Marijnen CA, Maas CP, Putter H, Rutten HJ, Stiggelbout AM, Meershoek-Klein Kranenbarg E, van de Velde CJ; Cooperative clinical investigators of the Dutch. Risk factors for sexual dysfunction after rectal cancer treatment. Eur J Cancer. 2009 Jun;45(9):1578-88. doi: 10.1016/j.ejca.2008.12.014. Epub 2009 Jan 13.
- Background: PubMed 22498730Lim KS, Tan CH. Diffusion-weighted MRI of adult male pelvic cancers. Clin Radiol. 2012 Sep;67(9):899-908. doi: 10.1016/j.crad.2012.01.016. Epub 2012 Apr 11.
- Background: PubMed 19959077Shihab OC, Heald RJ, Rullier E, Brown G, Holm T, Quirke P, Moran BJ. Defining the surgical planes on MRI improves surgery for cancer of the low rectum. Lancet Oncol. 2009 Dec;10(12):1207-11. doi: 10.1016/S1470-2045(09)70084-1.
- Background: PubMed 8095572Filler AG, Howe FA, Hayes CE, Kliot M, Winn HR, Bell BA, Griffiths JR, Tsuruda JS. Magnetic resonance neurography. Lancet. 1993 Mar 13;341(8846):659-61. doi: 10.1016/0140-6736(93)90422-d.
- Background: PubMed 18796657Takahara T, Hendrikse J, Yamashita T, Mali WP, Kwee TC, Imai Y, Luijten PR. Diffusion-weighted MR neurography of the brachial plexus: feasibility study. Radiology. 2008 Nov;249(2):653-60. doi: 10.1148/radiol.2492071826. Epub 2008 Sep 16.
- Background: PubMed 22705377van der Jagt PK, Dik P, Froeling M, Kwee TC, Nievelstein RA, ten Haken B, Leemans A. Architectural configuration and microstructural properties of the sacral plexus: a diffusion tensor MRI and fiber tractography study. Neuroimage. 2012 Sep;62(3):1792-9. doi: 10.1016/j.neuroimage.2012.06.001. Epub 2012 Jun 13.
- Background: PubMed 24838739Bertrand MM, Macri F, Mazars R, Droupy S, Beregi JP, Prudhomme M. MRI-based 3D pelvic autonomous innervation: a first step towards image-guided pelvic surgery. Eur Radiol. 2014 Aug;24(8):1989-97. doi: 10.1007/s00330-014-3211-0. Epub 2014 May 17.
- Background: PubMed 24812598Soler L, Nicolau S, Pessaux P, Mutter D, Marescaux J. Real-time 3D image reconstruction guidance in liver resection surgery. Hepatobiliary Surg Nutr. 2014 Apr;3(2):73-81. doi: 10.3978/j.issn.2304-3881.2014.02.03.
- Background: PubMed 19001653Chang KJ, Kamel IR, Macura KJ, Bluemke DA. 3.0-T MR imaging of the abdomen: comparison with 1.5 T. Radiographics. 2008 Nov-Dec;28(7):1983-98. doi: 10.1148/rg.287075154.
- Results publication: PubMed 29435745Wijsmuller AR, Giraudeau C, Leroy J, Kleinrensink GJ, Rociu E, Romagnolo LG, Melani AGF, Agnus V, Diana M, Soler L, Dallemagne B, Marescaux J, Mutter D. A step towards stereotactic navigation during pelvic surgery: 3D nerve topography. Surg Endosc. 2018 Aug;32(8):3582-3591. doi: 10.1007/s00464-018-6086-3. Epub 2018 Feb 12.
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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.
Daniel Grucker, MD, PhD principal investigator
Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS 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 acquisition - no contrast agent in people with Healthy Volunteers, 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 3 inclusion and 10 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 14 Mar 2018. 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?
Assessment of image quality to delineate and identify nerves (time frame: At the time of exam). 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 NCT02582346, which also lists 12 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 14 Mar 2018.