The aims of this study are 1) to examine which magnetic field strength (1.0, 1.5, or 3.0 T) 2) in combination with which fat-suppression technique (STIR or SPIR/SPAIR) results in the best DWIBS images, 3) to detemine which respiration technique…
ID
Source
Brief title
Condition
- Other condition
- Lymphomas NEC
- Lymphomas NEC
Synonym
Health condition
Het betreft onderzoek naar beeldkwaliteit en normale lymfeklieren bij gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1 a) Image quality of DWIBS obtained at different magnetic field strengths and
with different fat-suppression techniques: average apparent contrast-to-noise
ratio's with corresponding standard deviations of DWIBS-images obtained at
1.0 T, 1.5 T, and 3.0 T and with different fat-suppression techniques (STIR
versus SPIR/SPAIR) will be compared
1 b) Image quality of three respiration techniques in DWIBS of the liver: image
quality on a scale of 1 (poor) to 5 (very good) of breathhold, "respiratory
triggered, and free breathing scanning will be compared
2) A mean ADC with SD will be calculated for non-malignant (normal) lymph
nodes.
Secondary outcome
The number of non-analyzable images will be registered.
Background summary
Malignant tumors are the second most common cause of death and are responsible
for more than 12.5% of all deaths worldwide. Computed tomography (CT), positron
emission tomography (PET) and the recently introduced combined PET/CT play an
inportant role in staging and follow-up of malignancies. Unfortunately these
examinations are accompanied with a significant amount of radiation, which can
induce second malignancies on the long term. Moreover, the intravenous
application of a contrast agent necessary for CT may cause allergic reactions
and may cause contrastnephropathy. New magnetic resonance imaging (MRI)
techniques offer an alternative way for staging and follow-up of cancers,
including the malignant lymphomas. Whole-body MRI (WB-MRI), including
diffusion-weighted sequences (DWIBS), is a radiation-free method which allows
imaging of the body with excellent soft tissue contrast in a examination,
without the application of a contrast agent. The optimal parameters for the
recently developed DWIBS-technique, however, have not been established yet. It
is also unknown which lymph nodes on DWIBS images can be classified as
non-malignant (normal) and which lymph nodes on DWIBS images can be classified
as malignant.
Study objective
The aims of this study are 1) to examine which magnetic field strength (1.0,
1.5, or 3.0 T) 2) in combination with which fat-suppression technique (STIR or
SPIR/SPAIR) results in the best DWIBS images, 3) to detemine which respiration
technique results in the best image quality in DWIBS of the liver (breathhold
scanning, respiratory triggered scanning, or free breathing scanning), and 4)
to determine the apparent diffusion coefficient (ADC) of non-malignant (normal)
lymph nodes.
Study design
This will be a unicenter, prospective, diagnostic cohort study (timeschedule: 2
months). 15 volunteers will undergo a DWIBS-scan in each of the 3 different
scanners (1.0 T, 1.5 T, and 3.0 T MRI-scanners). Measurements will be made on
the obtained DWIBS-images.
Study burden and risks
Every volunteer will undergo 3 MRI-scans, with each MRI-scan being performed in
another scanner. The volunteer has to try to lie still during scanning. The
first MRI-scan takes approximately 60 minutes. During this scan, the volunteer
has to hold his/her breath during 20 seconds, which will be repeated 6 times.
The remaining two MRI-scans will each last approximately 45 minutes. Cumulative
duration is approximately 2* hours (1 x 60 + 2 x 45 minutes). All MRI-scans are
completely non-invasive and without any side-effects.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- male or female volunteers
- age: 18 years and older
- the participant must willingly give written informed consent prior to the start of the study
Exclusion criteria
- volunteers who underwent surgery in the past
- volunteers who had a malignancy in the past
- volunteers who have been or are suffering from a chronical inflammation or infection
- volunteers using medication at present
- volunteers who suffered from a transient infection within the past two months
- volunteers with symptoms possibly indicating an active inflammation or infection (e.g. fever, chills, night sweats, malaise, weight loss, fatigue, rhinorrhoe, coughing, throat ache, nausea, vomiting, diarrhea, etc.)
- volunteers with a general contraindication for MRI (including cardiovascular pacemakers, claustrofobia)
-volunteers who don't want to be informed about incidentally discovered lesions
-employees of the Department of Radiology of the UMC Utrecht
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 | NL17270.041.07 |