18F-FDG Tomography and Labeled Leukocyte Scintigraphy

Completed

• Conditions: Malignant Otitis Externa

• Registration Number: NCT05994768
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

The management of malignant otitis externa (MEO) is a major issue in patients who are often polypathological and fragile. Appropriate antibiotic therapy must be started quickly after the diagnosis is made and followed for a period of at least 6 weeks. Imaging plays a major role in assessing the extent of the infection and especially healing, after 6 weeks of antibiotic therapy. The persistence of an infection at the end of the treatment, observed in imaging, will allow a change of antibiotic line. This study consists in studying in a population affected by an OEM, the performance of PET/CT with 18F-FDG compared to scintigraphy with labeled leukocytes. The usefulness of the latter in the follow-up of the pathology after antibiotic therapy has already been proven in the literature. The study will aim to show that there is a superiority of 18F-FDG PET/CT compared to labeled leukocyte scintigraphy.

Study Timeline

• Study Start: 2020-12-18
• Primary Completion: 2023-07-12
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-16
• Study Completion: 2023-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

Exclusion Criteria

• patients who refuse to have their imaging data used

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
18F-FDG positron emission tomography	one day	measurement of standard uptake value
Labeled leukocyte scintigraphy	one day	measurement of standard uptake value

Trial Locations

Locations (1)

Verger Antoine; 🇫🇷 Vandoeuvre les Nancy cedex, France