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Use of a PET scan to quantify disease activity in patients with hearing loss due to otosclerosis.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21643
Enrollment
40
Registered
2010-10-29
Start date
2011-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Onderwerp: - Keel-, neus- en oorheelkunde - Otosclerose (fenestraal en cochleolabyrinthair) - PET/CT-beeldvorming Subject: - Otorhinolaryngology - Otosclerosis (fenestral and cochlear) - PET/CT imaging

Interventions

30 otosclerosis patients: 18F-fluoride PET scan of the head and neck with a low-dose CT scan for attenuation. Apart from that patients will undergo, or may already have undergone, a high-resolution CT

Sponsors

INITIATOR: J.J. Waterval P. Debyelaan 25 Postbus 5800 6202 AZ Maastricht (T) +31-(0)433876543 (E) J.Waterval@gmail.com
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Study patients: 1. Fenestral otosclerosis; 2. Cochlear otosclerosis. Control patients: 1. Clinically relevant reason to undergo a PET/CT-scan with 18F-fluoride, in which the head & neck region is scanned as part of the protocol.

Exclusion criteria

Exclusion criteria: Otosclerosis patients: 1. Prior ear surgery at the concerning ear; 2. Chronic otitis media or chronic mastoiditis; 3. Tympanosclerosis diagnosed at prior ear surgery; 4. Claustrophobia or the inability to lie still during the scan; 5. Active malignancy; 6. Generalised bone condition (except osteoporosis); 7. Pregnancy or lactation. Control patients: 1. A history of ear surgery, with the exception of tympanic tubes; 2. Otosclerosis; 3. Generalised bone condition (except osteoporosis).

Design outcomes

Primary

MeasureTime frame
Semiquantitative measurements (SUV) of patients and control subjects at different areas areas of interest.

Secondary

MeasureTime frame
1. Disease activity compared to degree and course of hearing loss; 2. Disease activity compared to computed tomography findings.

Contacts

Public ContactJ.J. Waterval

Postbus 5800

J.Waterval@gmail.com+31 (0)43 3876543

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)