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Feasibility Study of a New Magnetic Resonance Imaging Mini-capsule Device to Measure Whole Gut Transit Time in
Hayfa Sharif1,2, Nichola Abrehart1, Caroline L Hoad1,3
1Nottingham Digestive Diseases Centre and National Institute for Health Research (NIHR), Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, University of Nottingham, Nottingham, UK.
Insights
A new magnetic resonance imaging (MRI) method using mini-capsules offers a feasible and well-tolerated alternative to X-ray tests for assessing whole gut transit time (WGTT) in children with constipation.
Area of Science:
- Medical Imaging
- Paediatric Gastroenterology
- Medical Device Development
Background:
- Constipation affects 27,500 children annually in England, necessitating improved diagnostic tools.
- Current whole gut transit time (WGTT) assessment using X-ray radiopaque markers (ROM) has limitations including poor anatomical definition and undesirable radiation exposure in children.
- Objective assessment of WGTT is crucial for effective management of paediatric constipation.
Purpose of the Study:
- To develop and demonstrate the initial feasibility of a novel magnetic resonance imaging (MRI) based WGTT measurement as an alternative to the X-ray ROM test.
- To evaluate a new MRI-visible mini-capsule for assessing WGTT in paediatric constipation.
Main Methods:
- A small, inert polypropylene capsule filled with MRI-visible fat emulsion was developed.
- Sixteen constipated children and 19 healthy children (aged 7-18) ingested 24 mini-capsules daily for 3 days.
- Participants underwent MRI on days 4 and 7 to assess WGTT, with feasibility and tolerance evaluated.
Main Results:
- The MRI mini-capsules were successfully visualized in the colons of all participants, demonstrating feasibility.
- Mean WGTT was significantly longer in constipated patients (78 ± 35 hours) compared to healthy controls (36 ± 16 hours; P < 0.0001).
- The procedure was well-tolerated, with no significant changes in EuroQoL Visual Analogue Scale scores.
Conclusions:
- This first-in-child feasibility study confirms that MRI-based WGTT measurement is a viable and well-tolerated method for evaluating paediatric constipation.
- The developed MRI technique offers a promising, radiation-free alternative for assessing WGTT in children.
- This novel approach has the potential to improve the diagnostic and management strategies for paediatric constipation.
Objective:
In England, 27,500 children are referred annually to hospital with constipation. An objective measure of whole gut transit time (WGTT) could aid management. The current standard WGTT assessment, the x-ray radiopaque marker (ROM) test, gives poor definition of colonic anatomy and the radiation dose required is undesirable in children. Our objective was to develop an alternative magnetic resonance imaging (MRI) WGTT measure to the x-ray ROM test and to demonstrate its initial feasibility in paediatric constipation.
Methods:
With the Nottingham Young Person's Advisory Group we developed a small (8 × 4 mm), inert polypropylene capsule shell filled with MRI-visible fat emulsion. The capsule can be imaged using MRI fat and water in-phase and out-of-phase imaging. Sixteen patients with constipation and 19 healthy participants aged 7 to 18 years old were recruited. Following a common ROM protocol, the participants swallowed 24 mini-capsules each day for 3 days and were imaged on days 4 and 7 using MRI. The number of successful studies (feasibility) and WGTT were assessed. Participants' EuroQoL Visual Analogue Scale were also collected and compared between the day before the taking the first set of mini-capsules to the day after the last MRI study day.
Results:
The mini-capsules were imaged successfully in the colon of all participants. The WGTT was 78 ± 35 hours (mean ± standard deviation) for patients, and 36 ± 16 hours, P < 0.0001 for healthy controls. Carrying out the procedures did not change the EuroQoL Visual Analogue Scale scores before and after the procedures.
Conclusions:
Magnetic Resonance Imaging in Paediatric Constipation was a first-in-child feasibility study of a new medical device to measure WGTT in paediatric constipation using MRI. The study showed that the new method is feasible and is well tolerated.
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