Malignant Otitis ExternaOENNCT05994768
18F-FDG Tomography and Labeled Leukocyte Scintigraphy
An observational study of Malignant Otitis Externa, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Otitis Externa
- What is being tested?
- 18F-FDG PET/CT
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2020to 18 Oct 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with malignant otitis externa who received a 18F-FDG positron emission tomography and a labelled leukocyte scintigraphy
Who cannot join
- patients who refuse to have their imaging data used
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Malignant Otitis Externa
- Being tested
- 18F-FDG PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CTOther
Also called scintigraphy with labeled leukocytes
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-FDG positron emission tomography
measurement of standard uptake value
Measured: one day
Labeled leukocyte scintigraphy
measurement of standard uptake value
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start18 Dec 2020
- Primary completion12 Jul 2023
- Study completion18 Oct 2023
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 Malignant Otitis ExternaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994768
- Sponsor's protocol ID
- 2023PI003
- Acronym
- OEN
- Status last verified
- Jun 2026
- First submitted
- 9 Aug 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hurstel M, Vasseur A, Melki S, Veran N, Imbert L, Nguyen DT, Rumeau C, Verger A. Head-to-Head Comparison Between 18F-FDG PET and Leukocyte Scintigraphy to Monitor Treatment Responses in Necrotizing Otitis Externa. J Otolaryngol Head Neck Surg. 2024 Jan-Dec;53:19160216241288810. doi: 10.1177/19160216241288810.
PubMed 39417996
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05994768
- Acronym / sponsor ID
- OEN / 2023PI003
- Conditions
- Malignant Otitis Externa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 16 Aug 2023 (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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients with malignant otitis externa who received a 18F-FDG positron emission tomography and a labelled leukocyte scintigraphy
Key exclusion criteria (1 listed)
- patients who refuse to have their imaging data used
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 |
|---|---|---|
| 18F-FDG PET/CTAlso: scintigraphy with labeled leukocytesPatients 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. | Other | – |
Primary outcome
18F-FDG positron emission tomography
Time frame: one day
measurement of standard uptake value
Labeled leukocyte scintigraphy
Time frame: one day
measurement of standard uptake value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 39417996Hurstel M, Vasseur A, Melki S, Veran N, Imbert L, Nguyen DT, Rumeau C, Verger A. Head-to-Head Comparison Between 18F-FDG PET and Leukocyte Scintigraphy to Monitor Treatment Responses in Necrotizing Otitis Externa. J Otolaryngol Head Neck Surg. 2024 Jan-Dec;53:19160216241288810. doi: 10.1177/19160216241288810.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Otitis Externa, run by Central Hospital, Nancy, France at 1 site in 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 1 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: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-FDG positron emission tomography (time frame: one day). The study lists 2 primary outcomes in all. 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 NCT05994768, 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 25 Jun 2026.