Parotid TumorNEFAPANCT04613349
FArial NErf MRI in the Preoperative Assessment of PArotide Tumors
An observational study of Parotid Tumor, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
1. st visit: Inclusion, 3Tesla injected parotid MRI performed as part of routine care for characterization, to which two specific high resolution sequences will be added. Evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two… 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
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2021to 13 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 candidate for first line surgery for a parotid tumor
- Parotid tumor located near the trunk of the facial nerve and or its first branches of division according to the clinical examination of the ENT surgeon and the imaging data
- Affiliate or beneficiary of a social security scheme
- Written consent to participate in the study
Who cannot join
- Personal history of parotid homolateral surgery
- Absolute or relative contraindication to MRI
- Known hypersensitivity to gadolinic contrast media
- Pre or post operative period of a liver transplant
- Patient benefiting from a legal protection measure
- Pregnant or lactating woman
- Patient who has already benefited from a preoperative MRI to characterize a complete, well conducted and interpretable parotid lesion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation A De Rothschild
Paris, PARIS, 75019
a YAVCHITZ, 0148036454, ayavchitz@for.paris
adrien Collin
About this study
- st visit: Inclusion, 3Tesla injected parotid MRI performed as part of routine care for characterization, to which two specific high resolution sequences will be added. Evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two categories: on contact (≤ 5 mm) or at a distance (> 5 mm).
- nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI.
- rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.
- 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.
MRIOther
All patients included will benefit from the two methods of evaluating the anatomical relationships between the facial nerve and the parotid tumor:
- New medical imaging technique evaluated: high-resolution 3 Tesla parotid MRI with specific sequences and gadolinium injection;
- Gold standard: Intraoperative examination.
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
Measured: day 0
assessment by the surgeon during the excision surgery of the parotid lesion
assessment by the surgeon during the excision surgery of the parotid lesion
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start13 Jan 2021
- Primary completion13 Jan 2027 (estimated)
- Study completion13 May 2027 (estimated)
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
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613349
- Sponsor's protocol ID
- 2020-A02019-30
- Acronym
- NEFAPA
- Status last verified
- Dec 2025
- First submitted
- 7 Jul 2020
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FArial NErf MRI in the Preoperative Assessment of PArotide Tumors
- ClinicalTrials.gov ID
- NCT04613349
- Acronym / sponsor ID
- NEFAPA / 2020-A02019-30
- Conditions
- Parotid Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 13 May 2027 (estimated)
- First posted
- 3 Nov 2020 (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.
- st visit: Inclusion, 3Tesla injected parotid MRI performed as part of routine care for characterization, to which two specific high resolution sequences will be added. Evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two categories: on contact (≤ 5 mm) or at a distance (> 5 mm).
- nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI.
- rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 candidate for first line surgery for a parotid tumor
- Parotid tumor located near the trunk of the facial nerve and or its first branches of division according to the clinical examination of the ENT surgeon and the imaging data
- Affiliate or beneficiary of a social security scheme
- Written consent to participate in the study
Key exclusion criteria (7 listed)
- Personal history of parotid homolateral surgery
- Absolute or relative contraindication to MRI
- Known hypersensitivity to gadolinic contrast media
- Pre or post operative period of a liver transplant
- Patient benefiting from a legal protection measure
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 the two methods of evaluating the anatomical relationships between the facial nerve and the parotid tumor: 1. New medical imaging technique evaluated: high-resolution 3 Tesla parotid MRI with specific sequences and gadolinium injection; 2. Gold standard: Intraoperative examination. | Other | – |
Primary outcome
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
Time frame: day 0
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences.
assessment by the surgeon during the excision surgery of the parotid lesion
Time frame: day 0
assessment by the surgeon during the excision surgery of the parotid lesion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- 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.
1 site 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 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 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie YAVCHITZ (0148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurements by the radiologist on the high resolution 3Tesla MRI with specific sequences. (time frame: day 0). The study lists 2 primary outcomes in all. 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 5 Jan 2026.