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出境医 / 临床实验 / Intra-parotid Facial Nerve Tractography (R-PO19053)
Intra-parotid Facial Nerve Tractography (R-PO19053)
Study Description
Brief Summary:
The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parotid Tumor | Radiation: MRI with Facial nerve tractography | Not Applicable |
Detailed Description:
Surgery is the main treatment for parotid tumol, benign or malignant pathologies. The procedure requires a trunk search and a facial nerve dissection along its intraparotid length. This intervention entails a risk of facial paralysis.
MRI tractography is a new imaging technique that can characterize nerve fibers and their path.
The interest would be to allow the surgeon to best prepare the parotidectomy by locating the tumor in relation to the trunk and all the branches of the facial nerve.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors |
| Actual Study Start Date : | June 24, 2019 |
| Estimated Primary Completion Date : | December 24, 2020 |
| Estimated Study Completion Date : | June 24, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: patients operated on for parotid tumor
All consecutive patients operated on for parotid tumor.
|
Radiation: MRI with Facial nerve tractography
MRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging.
|
Outcome Measures
Primary Outcome Measures :
- Facial nerve's path [ Time Frame: Day 0 ]
Relations between the facial nerve's (the facial nerve's trunk s and the facial nerve's dissections) and the parotid gland will be studied. The nerve will be
- in front of the mass or behind the mass
- below the mass or above the mass
- outside the mass or inside the mass
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
inclusion criteria :
- Major patient
- Patient with initial parotid mass or recurrent
- Parotidian mass with surgical indication
- Benign or malignant
- With or without preoperative facial paralysis
- Patients consenting the protocol
exclusion criteria :
- Parotidian masses without surgical indication
- Patient with a classic contraindication to MRI
Contacts and Locations
Contacts
| Contact: Marc LABROUSSE | 03 26 78 37 81 ext 0033 | mlabrousse@chu-reims.fr |
Locations
| France | |
| Damien JOLLY | Recruiting |
| Reims, France | |
| Contact: Marc LABROUSSE 03 26 78 37 81 ext 0033 mlabrousse@chu-reims.fr | |
Sponsors and Collaborators
CHU de Reims
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 13, 2019 | ||||
| First Posted Date ICMJE | May 15, 2019 | ||||
| Last Update Posted Date | April 14, 2020 | ||||
| Actual Study Start Date ICMJE | June 24, 2019 | ||||
| Estimated Primary Completion Date | December 24, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Facial nerve's path [ Time Frame: Day 0 ] Relations between the facial nerve's (the facial nerve's trunk s and the facial nerve's dissections) and the parotid gland will be studied. The nerve will be
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intra-parotid Facial Nerve Tractography | ||||
| Official Title ICMJE | Intra-parotid Facial Nerve by MRI Tractography: Clinical vs Radiologic Description in Parotid Tumors | ||||
| Brief Summary | The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively. | ||||
| Detailed Description |
Surgery is the main treatment for parotid tumol, benign or malignant pathologies. The procedure requires a trunk search and a facial nerve dissection along its intraparotid length. This intervention entails a risk of facial paralysis. MRI tractography is a new imaging technique that can characterize nerve fibers and their path. The interest would be to allow the surgeon to best prepare the parotidectomy by locating the tumor in relation to the trunk and all the branches of the facial nerve. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
||||
| Condition ICMJE | Parotid Tumor | ||||
| Intervention ICMJE | Radiation: MRI with Facial nerve tractography
MRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging.
|
||||
| Study Arms ICMJE | Experimental: patients operated on for parotid tumor
All consecutive patients operated on for parotid tumor.
Intervention: Radiation: MRI with Facial nerve tractography
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 24, 2021 | ||||
| Estimated Primary Completion Date | December 24, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
inclusion criteria :
exclusion criteria :
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03950323 | ||||
| Other Study ID Numbers ICMJE | PO19053 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | CHU de Reims | ||||
| Study Sponsor ICMJE | CHU de Reims | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | CHU de Reims | ||||
| Verification Date | April 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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