The objective of this study is to acquire a set of images and associated technical information to facilitate regulatory submission of the pulse sequences
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
- Nervous system neoplasms malignant and unspecified NEC
- Cranial nerve disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Image quality.
Secondary outcome
NVT
Background summary
The technology comprising Magnetic Resonance (MR) imaging systems is under
continuous development in order to improve the quality of images, speed of
acquisition, and usability of MR devices. Collection of in vivo human data
plays an important role in enabling the technology to be investigated,
optimized, and validated.
Study objective
The objective of this study is to acquire a set of images and associated
technical information to facilitate regulatory submission of the pulse
sequences
Study design
This is a single-site; open-label, prospective research Study involving
patients.
Study burden and risks
With the screening for contraindications, no objective risks are inherent to
the use of the MRI and contrast.
3200 N. Grandview Blvd. 3200
Waukesha, WI 531881678
US
3200 N. Grandview Blvd. 3200
Waukesha, WI 531881678
US
Listed location countries
Age
Inclusion criteria
• Subject must be at least eighteen (18) years of age; and
• Subject must be willing and able to undergo verbal and written informed consent; and
• Subject must have a clinical indication for a head MRI with and without Gadolinium-based contrast agent administration
Exclusion criteria
• Any contraindication to administration of an MRI contrast agent.
• Off-label utilization of contrast agents administered for the subject*s clinical exam.
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 | NL41921.078.12 |