Parotid TumorParotidNCT05152056
MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors
An observational study of Parotid Tumor, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
What value is given to MRI diffusion and perfusion sequences in the diagnosis of parotid tumors? Is a fine needle aspiration associated with MRI systematically necessary? The aim of the research is to study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Parotid Tumor
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2021to 9 Dec 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 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: Minor and major subjects operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020 and having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.
Who may be able to join
- Major subject (≥18 years old)
- Minor subject (<18 years old)
- Operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020
- Having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.
- Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.
Who cannot join
- Subject (or his parents) who expressed his (their) opposition to participating in the study
- Lack of pathological or MRi results
- Subject under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'ORL et de Chirurgie Cervico-Faciale - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Role of MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors
What value is given to MRI diffusion and perfusion sequences in the diagnosis of parotid tumors? Is a fine needle aspiration associated with MRI systematically necessary? The aim of the research is to study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases.
- Conditions
- Parotid Tumor
- Keywords
- Parotid Tumor, Diffusion MRI, Perfusion MRI, Aspiration cytology, Fine-needle biopsy
- Medical subject headings
- Parotid Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases
Measured: Files analysed retrospectively from January 1, 2009 to June 30, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start15 Nov 2021
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
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 University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152056
- Sponsor's protocol ID
- 8454
- Acronym
- Parotid
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors
- ClinicalTrials.gov ID
- NCT05152056
- Acronym / sponsor ID
- Parotid / 8454
- Conditions
- Parotid Tumor
- Keywords
- Parotid Tumor, Diffusion MRI, Perfusion MRI, Aspiration cytology, Fine-needle biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 9 Dec 2021 (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.
What value is given to MRI diffusion and perfusion sequences in the diagnosis of parotid tumors? Is a fine needle aspiration associated with MRI systematically necessary? The aim of the research is to study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Minor and major subjects operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020 and having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.
Key inclusion criteria (5 listed)
- Major subject (≥18 years old)
- Minor subject (<18 years old)
- Operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020
- Having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.
- Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.
Key exclusion criteria (3 listed)
- Subject (or his parents) who expressed his (their) opposition to participating in the study
- Lack of pathological or MRi results
- Subject under guardianship, curatorship or safeguard of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases
Time frame: Files analysed retrospectively from January 1, 2009 to June 30, 2020 will be examined]
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 10 Dec 2021.
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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.
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 University Hospital, Strasbourg, France 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 3 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 10 Dec 2021. 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?
Study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases (time frame: Files analysed retrospectively from January 1, 2009 to June 30, 2020 will be examined]). 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 10 Dec 2021.