NCT06323798

Brief Summary

Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 15, 2024

Last Update Submit

March 15, 2024

Conditions

Pyocele; Sinus

Keywords

sinus, pyocele, mri

Outcome Measures

Primary Outcomes (1)

  • apparent diffusion coefficient

    apparent diffusion coefficient on a diffusion weighted MRI sequence

    5 years

Study Arms (2)

cases

patients with a paranasal sinus mri and a confirmed pyocele at bacteriologic sample reviewed in the medical file

Diagnostic Test: MRI

controls

patients with a paranasal sinus mri and a confirmed simple retention mucus at bacteriologic sample reviewed in the medical file

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_TEST

Standard paranasal sinus MRI

casescontrols

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with paranasal MRI

You may qualify if:

  • paranasal sinus MRI with a diffusion weighted sequence

You may not qualify if:

  • no clinical examination available
  • no bateriologic sample available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31169984BACKGROUND

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • romain gillet, md

    CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

romain gillet, md

CONTACT

0033383851811r.gillet@chru-nancy.fr

romain gillet

CONTACT

r.gillet@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 21, 2024

Study Start

April 28, 2024

Primary Completion

July 28, 2024

Study Completion

December 28, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

MRI is the proprety of the patient