The primary objective is to determine the repeatability of quantitative MRI measures in the healthy tissue on a diagnostic MRI system or hybrid MRI-linac system.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
het betreft gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the repeatability coefficient (within-coefficient
of variance) between the qMRI values measured during the test and retest
Secondary outcome
not applicable
Background summary
Quantitative magnetic resonance imaging (qMRI) biomarkers are used to monitor
and predict short and long-term treatment response in cancer patients. qMRI
techniques can either depict radiation-induced changes to the tumor and/or to
the surrounding healthy tissue. To develop qMRI techniques, it is necessary to
design scanning protocols for a particular anatomy and to evaluate the
precision of the measurements taken. For this, the repeatability of the
measurement needs to be established in a test-retest study. Prior to applying
these techniques in patients, the repeatability can be determined in cohorts of
healthy volunteers. Therefore, in this study, the repeatability of qMRI
measures will be investigated in cohorts of healthy volunteers, in order to
determine a baseline for qMRI biomarkers. To assess repeatability, a
test-retest study will be performed on the same MRI scanner.
Study objective
The primary objective is to determine the repeatability of quantitative MRI
measures in the healthy tissue on a diagnostic MRI system or hybrid MRI-linac
system.
Study design
Healthy volunteers will receive two quantitative MRI exams on the same system
within a couple of weeks, to access repeatability. MRI techniques that will be
tested in this protocol include, but are not limited to: diffusion-weighted
MRI, mDIXON MRI and T1/T2 mapping. Techniques that require administration of
contrast agents are excluded. MRI sessions will be performed outside of
clinical time.
Study burden and risks
The healthy volunteers will be schedule for two 1h MRI scanning sessions, with
a maximum duration of one hour each. The second MRI scanning session will be
within a month of the first one.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
• Volunteer, age >= 18 years, willing to be scanned two times within a couple of
weeks apart.
• Ability to understand and the willingness to sign a written informed consent
and a safety screening document
Exclusion criteria
• Contra*indications for an MRI examination.
• Pregnancy.
• Claustrophobia.
• Any clinically significant medical condition which, in the opinion of the
researchers, makes it undesirable to participate in the study or which could
jeopardize compliance with study requirements or severe psychiatric
illness/social situation.
• refusal to be informed about incidental findings on the MRI.
Additional in- and exclusion criteria may apply to specific techniques and are
listed in the technique specific study manuals provided. When these criteria
differ from those listed here, the technique specific in/exclusion criteria
will take precedence
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 | NL78118.031.21 |