1. to develop and improve new and existing MR sequences for inner ear imaging at 7T2. to investigate the clinical added value of 7T imaging (in comparison to 3T imaging)
ID
Source
Brief title
Condition
- Ear and labyrinthine disorders congenital
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end-points of this study are image quality and diagnostic value.
Secondary outcome
na
Background summary
Over the last decades treatment options for sensorineural hearing loss (SNHL)
have greatly improved thanks to new insights into pathophysiology and
development of new technologies, e.g. radiosurgery or implantable electronic
devices. Due to such advancements there is a growing interest in very detailed
evaluation of the inner ear and central auditory pathway in vivo. Such detailed
information can be obtained with ultra high field MRI. Yet, the technical
complexity accompanying higher magnetic field strengths and the particular
anatomic configuration of the temporal bone with many air-bone-fluid interfaces
giving cause to artifacts, make 7T imaging of the inner ear and retrocochlear
structures demanding. Previously we*ve shown that 7T imaging of the inner ear
is feasible, but further improvement and/or extension of the scan protocol is
required to meet the needs for therapy planning and therapy monitoring in
hearing loss.
Study objective
1. to develop and improve new and existing MR sequences for inner ear imaging
at 7T
2. to investigate the clinical added value of 7T imaging (in comparison to 3T
imaging)
Study design
Prospective observational.
Development of MRI sequences and improvements in acquisition parameters or
pulse sequences will be guided and monitored during quality review meetings
with physicists and radiologist(s). Image quality will be evaluated in a
comparative study between the standard clinical protocol performed on 1,5 or 3T
and the developed 7T sequences to investigate whether the image quality on 7T
outperforms lower field MRI for patient care and/or clinical research. The
diagnostic value will be evaluated in comparison to other available imaging
studies and/or peroperative findings and/or performance outcome (eg audiogram,
speech perception) and/or anatomical studies and/or literature values.
Study burden and risks
Participants of this study will undergo a 7T MRI scan additional to a
medium-field MRI (1,5T or 3T MRI), which is performed as part of their clinical
work-up. The duration of the 7T MR session will be scheduled for 1 hour.
Additional findings thanks to higher resolution on 7T MRI may be beneficial for
the patient in terms of higher diagnostic yield with potential improvement in
the therapeutic strategy. No risks are anticipated for the subjects in the
study population.
Albinusdreef 2
Leiden 2333 AZ
NL
Albinusdreef 2
Leiden 2333 AZ
NL
Listed location countries
Age
Inclusion criteria
eligible for MRI examination for evaluation of hearing loss
Exclusion criteria
contra-indications for MRI
Design
Recruitment
metc-ldd@lumc.nl
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 | NL53145.058.15 |