To measure the 18F-fluoride activity of otosclerosis in patients diagnosed with otosclerosis (by audiometry, CT scan and/or operative findings) in a different stage of their disease. If this diagnostic proves to be reliable and reproducible, this…
ID
Source
Brief title
Condition
- Ear and labyrinthine disorders congenital
- Middle ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study paramater:
To demonstrate that the 18F-fluoride PET scan has an additional value in the
diagnostic process in patients with otosclerosis.
Other research questions:
1. Is the bone metabolism in patients with otosclerosis in the area of interest
(inner ear) higher than in individuals without this disorder?
Outcome measure: Standard Uptake Value (SUV)
2. Is there a correlation between the abnormalities found on CT scan and the
abnormalities found on PET scan?
3. Can the PET scan predict the course of the process of
otosclerosis/otospongiosis in an individual patient?
Secondary outcome
4. Is there a correlation between the bone activity measured with PET scan and
the perioperative findings?
Background summary
Otosclerosis is diagnosed in many patients based upon the clinical
symptomatology and the audiologic examination. A high-resoluiton CT scan can
confirm the diagnosis. Until now only static diagnostics have played a role.
Static diagnostics exhibit the damage caused by otosclerosis until the moment
of the test. In certain cases there is a need for a dynamic diagnostic. With a
dynamic diagnostic the activity of the disease can be investigated and the
future hearing damage can be more accurately predicted. Other dynamic
diagnostics have been proposed in the past, without success due to different
reasons.
Study objective
To measure the 18F-fluoride activity of otosclerosis in patients diagnosed with
otosclerosis (by audiometry, CT scan and/or operative findings) in a different
stage of their disease. If this diagnostic proves to be reliable and
reproducible, this can be of important value in the process of planning surgery
or conventional hearing revalidation.
Study design
Observational patient-control study in which 3 groups of 10 patients with
confirmed otosclerosis undergo a 18F-fluoride PET/CT scan. The control group
consists of 10 individuals without an otologic history. 10 control patients
will be selected that have undergone a similar scan for other diagnostic
reasons.
Intervention
Patient population: PET/CT scan with 18F-fluorine. The tracer is administered
by means of an intravenous injection. After one hour the actual PET/CT scan is
performed. This is combined with a diagnostic CT scan of the skull base and a
low-dose CT scan for attenuation.
Control subjects: no intervention. This group is selected retrospectively for
analysis.
Study burden and risks
Radiation:
- 18F-fluoride scan: 5.4 mSv
- diagnostic CT scan of the inner ear area: 0.3 mv (patients only)
- attenuation low-dose CT scan of the head: 0.5 mSv (all individuals)
Compared to the average annual background radiation in the Netherlands: 2.0 mSv
Injection:
- possible redness or haematoma
- risk of phlebitis or lymphangitis
Logistic burden:
- PET scan is more time consuming than the conventional CT scan, around 2
hours.
P. Debyelaan 25
6229 HX Maastricht
NL
P. Debyelaan 25
6229 HX Maastricht
NL
Listed location countries
Age
Inclusion criteria
Otosclerosis patients:
* fenestral otosclerosis
* cochlear otosclerosis;Control patients:
* Clinically relevant reason to undergo a PET/CT-scan with 18F-fluorine, in which the head & neck region is scanned as part of the protocol. The indication for the scan will be set by the nuclear specialist and the referring specialist.
Exclusion criteria
Otosclerosis patients:
* Prior ear surgery at the concerning ear
* Chronic otitis media or chronic mastoiditis
* Tympanosclerosis diagnosed at previous ear surgery
* Claustrophobia or the inability to lie still during the scan
* Active malignancy
* Generalised bone condition (except osteoporosis)
* Pregnancy or lactation
* Patient refuses to be notified about additional findings on the PET-scan;Control patients:
* A history of ear surgery, with the exception of ear grommets
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31709.068.10 |