Pyocele; SinusNCT06323798
Diffusion Weighted MRI Enables Differential Diagnosis Between Pyocele and Mucocele
An observational study of Pyocele; Sinus, run by Central Hospital, Nancy, France.
Trial summary
Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pyocele; Sinus
- What is being tested?
- MRI
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2024to 28 Dec 2024
- 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 to 99 years
- All sexes
- Adult, Older adult
Study population: patients with paranasal MRI
Who may be able to join
- paranasal sinus MRI with a diffusion weighted sequence
Who cannot join
- no clinical examination available
- no bateriologic sample available
Trial locations and contacts
No sites are listed yet.
romain gillet contact
About this study
Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined
Read the detailed description
On the basis of the apparent diffusion coefficient, the content of a para nasal sinus could be defined as simple mucus or pus. This differentiation is very important for the clinician for prompt treatment. The aim of this study is to retrospectively measure this coefficient and to correlate it to clinica data.
- Conditions
- Pyocele; Sinus
- Being tested
- MRI
- Keywords
- sinus, pyocele, mri
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Standard paranasal sinus MRI
| Study group | Role | What they receive |
|---|---|---|
| cases | patients with a paranasal sinus mri and a confirmed pyocele at bacteriologic sample reviewed in the medical file Receives: Diagnostic Test: MRI | |
| controls | patients with a paranasal sinus mri and a confirmed simple retention mucus at bacteriologic sample reviewed in the medical file Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
apparent diffusion coefficient
apparent diffusion coefficient on a diffusion weighted MRI sequence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start28 Apr 2024 (estimated)
- Primary completion28 Jul 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pyocele; SinusStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, 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-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- romain gillet, md, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323798
- Sponsor's protocol ID
- 2024PI035
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: MRI is the proprety of the patient
Publications
Radulesco T, Scemama U, Mancini J, Moulin G, Dessi P, Michel J, Varoquaux A. Role of diffusion-weighted imaging in the discrimination of purulent intrasinusal content: A retrospective study. Clin Otolaryngol. 2019 Sep;44(5):762-769. doi: 10.1111/coa.13388. Epub 2019 Jul 23.
PubMed 31169984
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Weighted MRI Enables Differential Diagnosis Between Pyocele and Mucocele
- ClinicalTrials.gov ID
- NCT06323798
- Acronym / sponsor ID
- 2024PI035
- Conditions
- Pyocele; Sinus
- Keywords
- sinus, pyocele, mri
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 28 Apr 2024 (estimated)
- Primary completion
- 28 Jul 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 21 Mar 2024 (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.
Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined
Detailed description
On the basis of the apparent diffusion coefficient, the content of a para nasal sinus could be defined as simple mucus or pus. This differentiation is very important for the clinician for prompt treatment. The aim of this study is to retrospectively measure this coefficient and to correlate it to clinica data.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: MRIpatients with a paranasal sinus mri and a confirmed pyocele at bacteriologic sample reviewed in the medical file |
| controls | – | Diagnostic Test: MRIpatients with a paranasal sinus mri and a confirmed simple retention mucus at bacteriologic sample reviewed in the medical file |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with paranasal MRI
Key inclusion criteria (1 listed)
- paranasal sinus MRI with a diffusion weighted sequence
Key exclusion criteria (2 listed)
- no clinical examination available
- no bateriologic sample available
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 |
|---|---|---|
| MRIStandard paranasal sinus MRI | Diagnostic test | cases, controls |
Primary outcome
apparent diffusion coefficient
Time frame: 5 years
apparent diffusion coefficient on a diffusion weighted MRI sequence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 31169984Radulesco T, Scemama U, Mancini J, Moulin G, Dessi P, Michel J, Varoquaux A. Role of diffusion-weighted imaging in the discrimination of purulent intrasinusal content: A retrospective study. Clin Otolaryngol. 2019 Sep;44(5):762-769. doi: 10.1111/coa.13388. Epub 2019 Jul 23.
- Individual participant dataSharing planned: No. MRI is the proprety of the patient
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.
romain gillet contact
romain gillet, md principal investigator
CHRU de Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Pyocele; Sinus, run by Central Hospital, Nancy, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact romain gillet, md (0033383851811, r.gillet@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apparent diffusion coefficient (time frame: 5 years). 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 NCT06323798, which also lists 1 linked publication.
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 21 Mar 2024.