Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01347918
Status:
SUSPENDED
Last Update Posted:
2015-04-09
First Post:
2011-05-03
Brief Title:
1H-19F Gastrointestinal MRI in Health and IBS
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Small Intestinal Transit and Motor Function in Health and IBS Patients Studied by Combined 1H and 19F Magnetic Resonance Imaging
Status:
SUSPENDED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Technical problems
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-MD-0005 | OTHER | Swissmedic | None |