NCT05994768

Brief Summary

The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy in patients with a malignant otitis externa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 18, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

August 9, 2023

Last Update Submit

November 27, 2023

Conditions

Malignant Otitis Externa

Outcome Measures

Primary Outcomes (2)

  • 18F-FDG positron emission tomography

    measurement of standard uptake value

    one day

  • Labeled leukocyte scintigraphy

    measurement of standard uptake value

    one day

Interventions

18F-FDG PET/CTOTHER

Patients who underwent an 18F-FDG PET/CT examination and a labeled leukocyte scintigraphy before and after antibiotic therapy in the case of management of an EO.

Also known as: scintigraphy with labeled leukocytes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent an 18F-FDG positron emission tomography examination and a labeled leukocyte scintigraphy before and after antibiotic therapy in the case of management of an malignant otitis externa.

You may qualify if:

  • patients with malignant otitis externa who received a 18F-FDG positron emission tomography and a labelled leukocyte scintigraphy

You may not qualify if:

  • patients who refuse to have their imaging data used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Verger Antoine

Vandœuvre-lès-Nancy, 54511, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 16, 2023

Study Start

December 18, 2020

Primary Completion

July 12, 2023

Study Completion

October 18, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

FR(1)