Comparison of MRI with Colonoscopy for CGD-associated colitis
Research type
Research Study
Full title
Colonoscopy versus MRI in Chronic Granulomatous Disease-associated colitis
IRAS ID
177466
Contact name
David Lowe
Contact email
Sponsor organisation
Royal Free London NHS Trust Department of Research and Development
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Chronic granulomatous disease (CGD) is a primary (genetic) immune deficiency disease caused by abnormalities in the function of white blood cells. Affected patients suffer recurrent bacterial and fungal infections but they also develop excessive ‘inflammation’ in some organs. This includes a colitis (inflamed colon) which mimics other inflammatory bowel diseases like Crohn’s disease. Colonoscopy (a telescope examination of the bowel) is frequently performed to evaluate colitis in CGD, but this is an invasive procedure. Magnetic resonance imaging (MRI), a safe imaging procedure that does not utilise radiation, has recently been demonstrated to be useful for the assessment of other inflammatory bowel diseases.
The proposed study aims to compare MRI with colonoscopy for the assessment of CGD-associated colitis. It will assess patient satisfaction with each investigation via questionnaire. The study will also compare both modalities with possible surrogate markers of disease activity: a clinical score (from history and examination), a faecal test for inflammation called ‘calprotectin’, blood markers of inflammation and biopsy findings.
The study will prospectively recruit 15 patients diagnosed with CGD. All consenting patients will be assessed for clinical disease activity using the scoring system. Within one week of this appointment they will provide a stool sample to exclude infection and for measurement of faecal calprotectin; they will then commence a colonoscopy preparation drink which empties the bowel. The following day they will undergo a MRI scan (after also ingesting a MRI contrast drink) and a colonoscopy. Following each procedure they will be given questionnaires. The MRI, the bowel appearance at colonoscopy and the biopsy findings will all be carefully scored.
The primary outcome measure will be correlation between MRI and colonoscopy scores. Secondary analyses will correlate these scores with the clinical score for colitis and with measures of inflammation, as well as establishing relative satisfaction.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/1334
Date of REC Opinion
18 Sep 2015
REC opinion
Favourable Opinion