OEN: 18F-FDG Tomography and Labeled Leukocyte Scintigraphy

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05994768
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Anticipated Duration (Months): 32
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Otitis Externa	Other: 18F-FDG PET/CT

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 Design

• Study Type: Observational
• Anticipated Enrollment: 18 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Comparison of the Performance of 18F-FDG PET/CT With That of Labeled Leukocyte Scintigraphy in the Follow-up of Malignant Otitis Externa.
• Actual Study Start Date: Dec 18, 2020
• Actual Primary Completion Date: Jul 12, 2023
• Anticipated Study Completion Date: Aug 18, 2023

Outcome Measures

Primary Outcome Measures

1. 18F-FDG positron emission tomography [one day]

   measurement of standard uptake value (max and mean)

2. Labeled leukocyte scintigraphy [one day]

   measurement of standard uptake value (max and mean)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Verger Antoine	Vandoeuvre les Nancy cedex		France	54511

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antoine VERGER, MD, PhD, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05994768
• Other Study ID Numbers: 2023PI003
• First Posted: Aug 16, 2023
• Last Update Posted: Aug 16, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Otitis; Otitis Externa; Fluorodeoxyglucose F18

Study Results

No Results Posted as of Aug 16, 2023