The aim of this study is to evaluate 3D dynamic MRI as a diagnostic tool in the assessment of small bowel motility using several new acquisition and post-processing techniques. For the acquisition of the MR images the SPatial Modulation of…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This pilot study is to assess whether these 3D dynamic MRI acquisition and
post-processing techniques can be used as a tool to detect and quantify small
bowel motility. The main outcome parameter is detection of small bowel
motility.
Secondary outcome
Secondary outcome parameter is the validation and comparison of the two methods
by demonstrating the effects of motility modification.
Background summary
Small bowel motility disorders are frequently found in a variety of gastro
intestinal diseases, e.g. irritable bowel syndrome (IBS), inflammatory bowel
disease (IBD), chronic idiopathic intestinal pseudo obstruction (CIIP) and
ileus. Dynamic Magnetic Resonance Imaging (MRI) is playing an evolving role in
the assessment of bowel motility in patients with inflammatory bowel disease
(IBD). Recently new developed 2D and 3D dynamic MRI techniques have been
proposed for the assessment of small bowel motility.
Study objective
The aim of this study is to evaluate 3D dynamic MRI as a diagnostic tool in the
assessment of small bowel motility using several new acquisition and
post-processing techniques. For the acquisition of the MR images the SPatial
Modulation of Magnetization (SPAMM) sequence and the Motility Accelerating
(MotAc) sequence will be used. To accelerate the acquisition of the scans, two
acceleration techniques (sensitivity encoding (SENSE) and compressed sensing
(CS)) will be used and evaluated for acquiring scans with a higher temporal
resolution. The registered motion is quantified using two analysis techniques.
A scale-space based analysis will be used for the images acquired with the
SPAMM sequence, allowing quantification of the motility frequencies and
amplitudes. An optical flow analysis will be used for the images acquired with
the MotAc sequence to produce a motility *map* and to provide a surrogate for
motility. Conditions will be maintained equal during scan sessions to test the
reproducibility of the methods.
Study design
42 consecutive healthy volunteers with no history of gastrointestinal disorders
will be included in this prospective study. All volunteers will undergo a MRI
examination after 4 hours of fasting and minimal bowel preparation. Six
subjects will be administered a spasmolytic agent (scopolaminebutyl) to alter
the bowel motility. These scans are used for assessing the MRI acceleration
techniques. Thirty subjects are presented with a *food challenge* after the
first baseline scans. After ingestion of the motility modifying substance the
subject will be scanned several times in the following 30 min. Recruitment of
volunteers will take place by means of advertising.
Study burden and risks
Risks for the subjects undergoing the MRI examination are minimal. MRI is a
diagnostic procedure so there are no direct therapeutic effects. Exclusion
criteria for this study are an age of less than 18 years or more than 45 years
and the inability to hold breath for 25 seconds. Other exclusion criteria
include the contraindications to undergo MRI; pacemakers, claustrophobia and
pregnancy. Further exclusion criteria exist regarding the use of intravenous
injection of Scopolaminebutyl, including glaucoma or severe cardiac arrhythmia,
in those individuals scheduled for administration of this drug. Possible side
effects of Scopolaminebutyl are dry mouth and blurred vision. There is no
benefit for the healthy volunteers, except for a remuneration (70 euros) and
reimbursement of travel expenses. The outcomes of this study can be used in
evaluating the clinical utility of this method. If these methods prove to be a
validated tool in detecting small bowel motility, future clinical studies will
be planned.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Healthy, human volunteers who are willing to undergo minimal bowel preparation and magnetic resonance imaging (MRI) and who are willing to give informed consent.
Exclusion criteria
An age of less than 18 years or more than 45 years, subjects who were unable to give informed consent, the inability to hold breath for 25 seconds, history of abdominal surgery, gastrointestinal diseases or current gastrointestinal symptoms. Furthermore exclusion criteria are (relative) contraindications to undergo MRI; pacemakers, claustrophobia and pregnancy. For the subjects participating in the first part of the study additional exclusion criteria are (relative) contraindications for the use of intravenous injection of butylscopolamine. For the subjects participating in the second part of the study additional exclusion criteria are contraindications for the use of Nutridrink Juice style Apple (the motility modifying substance).
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 | NL54884.018.15 |