18F-fluoride PET-scan as complementary diagnostic medium for patients with otosclerosis - A pilot study
- Conditions
- fixation of the stapesotosclerosis1001399510027584
- Registration Number
- NL-OMON36729
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study paramater:<br /><br><br /><br>To demonstrate that the 18F-fluoride PET scan has an additional value in the<br /><br>diagnostic process in patients with otosclerosis.<br /><br><br /><br>Other research questions:<br /><br><br /><br>1. Is the bone metabolism in patients with otosclerosis in the area of interest<br /><br>(inner ear) higher than in individuals without this disorder?<br /><br>Outcome measure: Standard Uptake Value (SUV)<br /><br>2. Is there a correlation between the abnormalities found on CT scan and the<br /><br>abnormalities found on PET scan?<br /><br>3. Can the PET scan predict the course of the process of<br /><br>otosclerosis/otospongiosis in an individual patient?</p><br>
- Secondary Outcome Measures
Name Time Method <p>4. Is there a correlation between the bone activity measured with PET scan and<br /><br>the perioperative findings?</p><br>