Measurement of Intestinal Blood Flow
Research type
Research Study
Full title
Development and validation of ultrasonic assessment of intestinal blood flow measurement for use in clinical trials
IRAS ID
254475
Contact name
Mark Thursz
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The aim of this study is to generate a validated imaging method which can be used in the future, to measure the intestinal blood flow response to novel pharmaceutical agents. This should be sensitive, reproducible and measurements should have a low coefficient of variation. Specifically, the study will compare the sensitivity and variation in measurements of intestinal blood flow determined by ultrasound Doppler and Contrast-enhanced Ultrasound (CEUS) after injection of GLP-2 analogue Teduglutide and saline.
Such a validated biomarker methodology could be used to generate proof of mechanism (POM) data for novel therapeutic agents targeting gastrointestinal conditions such as short bowel syndrome (SBS), IBD and Crohn's Disease, thereby allowing an early assessment of their efficacy potential. If successful, the methodology under evaluation could lead to a test predictive of efficacy on a single dose administration of a novel agent in patients.
Specifically the study will compare the sensitivity and variation in measurements of intestinal blood flow determined by ultrasound Doppler and Contrast-enhanced Ultrasound (CEUS).REC name
London - Fulham Research Ethics Committee
REC reference
19/LO/1766
Date of REC Opinion
21 Feb 2020
REC opinion
Further Information Favourable Opinion