Parotid TumorFACPARNCT04104802
Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors
An observational study of Parotid Tumor, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites in France.
Trial summary
Preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ENT surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Tumor
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2019to Oct 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patient candidate for first-line surgery for a parotid tumor
Who may be able to join
- Patient over 18 years old
- Patient seeking first-line surgery for a parotid tumor (single or multiple, benign or malignant)
- Parotidian tumor located near the trunk of the facial nerve and / or its first division branches (temporofacial and cervicofacial), during a clinical evaluation performed by the surgeon in preoperative consultation
- Patient affiliated or beneficiary of a social security scheme
- Written consent to participate in the study
Who cannot join
- Personal history of ipsilateral parotid surgery
- Contraindication to MRI (electronic device, metallic foreign body, claustrophobia)
- Known hypersensitivity to gadolinium contrast agents
- Renal impairment known: glomerular filtration rate <30 mL / min
- Pre or post-operative period of liver transplantation
- Patient benefiting from a legal protection measure
- Pregnant or lactating woman
Trial locations and contacts
4 sites in 1 country.
France4 sites
Fondation Adolphe De Rothschild
Paris
Hôpital Saint Joseph
Paris
Institut Arthur Vernes
Paris
Hôpital FOCH
Suresnes
About this study
Preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ENT surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure
Read the detailed description
- st visit: Inclusion, parotid MRI 3Tesla high resolution with specific sequences and gadolinium injection performed at the A. de Rothschild Foundation. Evaluation by two radiologists of the exact position of the parotid tumor with respect to the trunk of the facial nerve and its first branches, classified into two categories: contact (≤ 5 mm) or distance (> 5 mm).
- nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as those collected by the radiologists after the MRI. The surgeon will not be aware of the data concerning the ratios of parotid tumor to facial nerve collected on MRI sequences for research purposes.
- Conditions
- Parotid Tumor
- Being tested
- MRI
- Medical subject headings
- Parotid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
All patients included will benefit from both methods of assessing anatomical relationships between the facial nerve and the parotid tumor:
- New medical imaging technique evaluated: 3 Tesla Parotidic MRI High Resolution with Specific Sequences and Gadolinium Injection 2) Standard Gold: Intraoperative Exam
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sensitivity of a high-resolution 3 Tesla MRI with gadolinium injection with specific sequences versus intraoperative findings of the surgeon (gold standard), to evaluate the anatomic relationships between parotid tumor and facial nerve.
Sensitivity of new MRI sequences to determine whether the parotid tumor is in contact or at a distance from the facial nerve (common core and first division branches) in comparison with the intra-operative examination (gold standard).
The contact between the parotid tumor and the trunk of the facial nerve or its first branches of division is a binary qualitative variable with modalities defined as:
- "Yes": tumor on contact (distance between the tumor and the trunk of the facial nerve or its first branches between 0 and 5 mm)
- "No": trunk of the facial nerve or its first divisional branches located at a distance (ie more than 5mm from the parotid tumor).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: refusal of the ansm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid TumorStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104802
- Sponsor's protocol ID
- ACN_2019_12
- Acronym
- FACPAR
- Status last verified
- Feb 2020
- First submitted
- 24 Jun 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors
- ClinicalTrials.gov ID
- NCT04104802
- Acronym / sponsor ID
- FACPAR / ACN_2019_12
- Conditions
- Parotid Tumor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: refusal of the ansm
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 26 Sep 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.
Preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ENT surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure
Detailed description
- st visit: Inclusion, parotid MRI 3Tesla high resolution with specific sequences and gadolinium injection performed at the A. de Rothschild Foundation. Evaluation by two radiologists of the exact position of the parotid tumor with respect to the trunk of the facial nerve and its first branches, classified into two categories: contact (≤ 5 mm) or distance (> 5 mm).
- nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as those collected by the radiologists after the MRI. The surgeon will not be aware of the data concerning the ratios of parotid tumor to facial nerve collected on MRI sequences for research purposes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient candidate for first-line surgery for a parotid tumor
Key inclusion criteria (5 listed)
- Patient over 18 years old
- Patient seeking first-line surgery for a parotid tumor (single or multiple, benign or malignant)
- Parotidian tumor located near the trunk of the facial nerve and / or its first division branches (temporofacial and cervicofacial), during a clinical evaluation performed by the surgeon in preoperative consultation
- Patient affiliated or beneficiary of a social security scheme
- Written consent to participate in the study
Key exclusion criteria (7 listed)
- Personal history of ipsilateral parotid surgery
- Contraindication to MRI (electronic device, metallic foreign body, claustrophobia)
- Known hypersensitivity to gadolinium contrast agents
- Renal impairment known: glomerular filtration rate <30 mL / min
- Pre or post-operative period of liver transplantation
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 |
|---|---|---|
| MRIAll patients included will benefit from both methods of assessing anatomical relationships between the facial nerve and the parotid tumor: 1) New medical imaging technique evaluated: 3 Tesla Parotidic MRI High Resolution with Specific Sequences and Gadolinium Injection 2) Standard Gold: Intraoperative Exam | Device | – |
Primary outcome
To determine the sensitivity of a high-resolution 3 Tesla MRI with gadolinium injection with specific sequences versus intraoperative findings of the surgeon (gold standard), to evaluate the anatomic relationships between parotid tumor and facial nerve.
Time frame: 1 day
Sensitivity of new MRI sequences to determine whether the parotid tumor is in contact or at a distance from the facial nerve (common core and first division branches) in comparison with the intra-operative examination (gold standard). The contact between the parotid tumor and the trunk of the facial nerve or its first branches of division is a binary qualitative variable with modalities defined as: * "Yes": tumor on contact (distance between the tumor and the trunk of the facial nerve or its first branches between 0 and 5 mm) * "No": trunk of the facial nerve or its first divisional branches located at a distance (ie more than 5mm from the parotid tumor).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parotid Tumor, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
To determine the sensitivity of a high-resolution 3 Tesla MRI with gadolinium injection with specific sequences versus intraoperative findings of the surgeon (gold standard), to evaluate the anatomic relationships between parotid tumor and facial nerve. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2020.