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1H-19F Gastrointestinal MRI in Health and IBS

NCT01347918 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2015-04-09

No results posted yet for this study

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

Conditions

  • Irritable Bowel Syndrome

Interventions

DEVICE

19F capsule

Two 19F capsules, one filled with hexafluorobenzene (HFB) and the other filled with perfluoro-15-crown-5-ether (PCE) will be administered orally together with 100 ml of water.

DIETARY_SUPPLEMENT

sterculia

7g of sterculia will be ingested over one week together with the normal breakfast.

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Werner Schwizer, Prof. MD · University Hospital Zurich, Gastroenterology & Hepatology

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347918 on ClinicalTrials.gov