Magnetic Resonance Imaging Assessment of Small Bowel Motility

Motility Disorder of Intestine Clinical Trial

Official title:

Post-Hoc Analysis of Dynamic Magnetic Resonance Sequences to Establish Descriptive Metrics for Small Bowel Motility in Vivo

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02754869
• Other study ID #: 11/0307
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2016
• Last updated: April 25, 2016
• Start date: February 2011
• Est. completion date: August 2018

Study information

• Verified date: November 2015
• Source: University College, London
• Contact: Alex Menys
• Email: alex.meny.09[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

This project involves the development, validation and application of a novel test using MRI to assess gastrointestinal motility a vital process that mixes the contents of our digestive tract. This process frequently becomes deranged in conditions like chronic constipation, Parkinson's and Crohn's disease.

Description:

Gastrointestinal motility refers to the contractile actions in the gut that serve to mix our food and propel it through out digestive tract. Although known to be involved in a range of conditions like chronic constipation, Parkinson's and Crohn's disease, investigator have never had effective tests with which to study the process. Advances in medical imaging technologies now make it possible to both see and quantify this process non-invasively using MRI. In this study the investigator first of all validate that our MRI based analysis is robust and valid, producing predictable results against range of known stimuli. The investigator then apply the technique to a cohort of participants with Chronic Intestinal Pseudo-Obstruction. These participants are known to have hypo-motile small bowels and demonstration with our MRI technique would serve as further validation. The investigator also investigate two cohorts of people with and without gastrointestinal diseases to better understand how the technique may work in the clinical setting.

By the end of this project The investigator will have generated robust initial evidence to validate our MRI technique and clinical data to inform use further research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

ELIGIBILITY CRITERIA - CONTROL SUBJECTS DRUG STUDY:

• Adult (>16 years)

• Body Mass Index within the range of (18---25)

ELIGIBILITY CRITERIA - DYSMOTILITY SUBJECTS DRUG STUDY:

• Adult patients (>16 years) 2

• Dysmotility diagnosis including CIPO

• Body Mass Index within the range of (18---35)

ELIGIBILITY CRITERIA - REFERENCE RANGE STUDY (NORMAL PARTICIPANTS):

• Adult (>16 years)

ELIGIBILITY CRITERIA - REFERENCE RANGE STUDY (DYSMOTILITY/IBS):

• Adult patients (>16 years)

• Dysmotility, CIPO or IBS diagnosis

ELIGIBILITY CRITERIA - DYSMOTILITY REVERSIBILITY STUDY:

• Adult (>16 years)

• Known small bowel Crohn's disease starting anti TNF alpha medication or undergoing endoscopic small bowel stricture dilatation.

Exclusion Criteria:

EXCLUSION CRITERIA - CONTROL SUBJECTS DRUG STUDY:

• Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)

• Inability to give consent

• Treatment for any chronic illness

• Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within one week of the scan.

• Cardiac symptoms (palpitations).

• Abnormal GI symptoms (eg. constipation, diarrhea, bloating, pain) as per the Rome III criteria for Irritable Bowel Syndrome

• Pregnancy

• Asthma EXCLUSION CRITERIA - DYSMOTILITY SUBJECTS DRUG STUDY: (18) Version 4.1

• Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)

• Inability to give consent

• Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within 1---3 days (or according to half life of drug) of the scan.

• Cardiac symptoms (palpitations).

• Pregnancy

• Asthma

EXCLUSION CRITERIA - REFERENCE RANGE STUDY (NORMAL PARTICIPANTS):

• Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)

• Inability to give consent 3. Treatment for any chronic illness

• Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within 1---3 days (or according to half life of drug) of the scan.

EXCLUSION CRITERIA - REFERENCE RANGE STUDY (DYSMOTILITY/IBS):

• Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)

• Inability to give consent

• Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within 1---3 days (or according to half life of drug) of the scan.

EXCLUSION CRITERIA - DYSMOTILITY REVERSIBILITY STUDY:

• Any contraindications to MRI scans (e.g. Implanted cardiac pacemaker, defibrillator device)

• Inability to give consent

• Use of laxatives, anti---diarrhoeals or any drugs affecting GI motility (including NSAIDs) prohibited within 1---3 days (or according to half life of drug) of the scan.

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Intestinal Diseases
• Motility Disorder of Intestine

Locations

Country	Name	City	State
United Kingdom	Centre for Medical Imaging	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the reproducibility of software quantified small bowel motility in normal individuals using processed MRI derived dynamic small bowel sequences.		7 years	No
Primary	To assess the ability of the software to detect changes in small bowel motility after provocation with a known pro or anti-kinetic agent in normal individuals		7 years	No
Primary	To evaluate the variation in software quantified small bowel motility according to the positioning of the image slice in the abdomen during data acquisition.		7 years	No
Primary	To compare dysmotility patients motility to that of normal controls with and in the absence of pro---kinetic agent.		7 years	No
Primary	To establish basal bowel motility reference ranges in a larger cohort of control, dysmotility and irritable bowel syndrome subjects.		7 years	No
Primary	To assess the reversibility of dysmotility after treatment of the primary underlying condition, if known		7 years	No