1H-19F Gastrointestinal MRI in Health and IBS

Suspended

• Conditions: Irritable Bowel Syndrome
• Interventions: Device: 19F capsule; Dietary Supplement: sterculia

• Registration Number: NCT01347918
• Lead Sponsor: University of Zurich

Brief Summary

The aim of this project is to demonstrate and validate the ionizing radiation free and non invasive assessment of small intestinal anatomy, content and function in healthy and disease by a newly developed combined proton (1H) and fluorine (19F) magnetic resonance imaging (MRI) framework. Meal induced and pathology related alterations in small intestinal motor activity, gas distribution and anatomy of healthy volunteers and patients with irritable bowel syndrome (IBS) will be analyzed with this non invasive MRI approach.

The multinuclear imaging framework consists of a 1H and 19F capable clinical 3T MRI system with standard 1H abdominal surface coils, a dual-channel transmit-receive abdominal 19F surface coil, fluorine labelled impermeable and biocompatible capsules for oral administration (19F capsule) and a 19F projection imaging sequence allowing for the non-invasive detection of the gastrointestinal positions of single and multiple ingested capsules in real time. Dedicated post-processing algorithms are applied to extract parameters of intestinal motor activity from the detected intraluminal capsule movements.

The proposed unique imaging modality allows for the concurrent, non invasive and repeated analysis of important physiologic parameters of intestinal function together with detailed anatomical information and thus presents an ideal tool for the evaluation of the analyzed parameters as potential biomarkers in IBS.

* Trial with medical device

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-05
• Study Start: 2011-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	sterculia	Healthy controls
control	19F capsule	Healthy controls
IBS	19F capsule	Patients that fulfil the Rome III criteria for irritable bowel syndrome (IBS)
IBS	sterculia	Patients that fulfil the Rome III criteria for irritable bowel syndrome (IBS)

Primary Outcome Measures

Name	Time	Method
Small intestinal transit time in minutes	Regularly over 4 hours

Secondary Outcome Measures

Name	Time	Method
Small intestinal transport velocity	Regularly over 4 hours
Local intestinal residence times	Regularly over 4 hours.
Volume and distribution of intestinal gas	Regularly over 4 hours.
Small intestinal motor activity index	At 4 hours
Small intestinal length and intestinal course	at 4 hours

Trial Locations

Locations (1)

University Hospital Zurich, Gastroenterology; 🇨🇭 Zurich, Switzerland