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18F-fluoride PET-scan as complementary diagnostic medium for patients with otosclerosis - A pilot study

18F-fluoride PET-scan as complementary diagnostic medium for patients with otosclerosis - A pilot study - 18F-fluoride PET-scan for otosclerosis

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36729
Enrollment
40
Registered
2011-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fixation of the stapes otosclerosis

Interventions

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 diagno

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
4. Is there a correlation between the bone activity measured with PET scan and the perioperative findings?—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)