PET-MR imaging iDOSH study
Research type
Research Study
Full title
Pilot study to assess [18F]-FBA-A20FMDV2 ([18F]-IMAFIB) PET-MR imaging for the detection and quantitation of early inflammation/fibrosis in patients with steatohepatitis and chemotherapy-associated steatohepatitis in hepatic metastatic disease (iDOSH)
IRAS ID
213343
Contact name
Duncan Spalding
Contact email
Sponsor organisation
Imperial Joint Research Compliance Office
Duration of Study in the UK
1 years, 0 months, 7 days
Research summary
Fatty liver disease (FLD) is currently one of the most important clinical areas to affect health in the UK. It occurs in ~10-25% of the general population, increasing to ~75% in those that are obese. Approximately 10% of people with FLD then go on to develop steatohepatitis (SH), a more serious liver condition characterised by fat accumulation and inflammation. SH then usually progresses to early and late fibrotic stages, through to cirrhosis and liver failure. In addition, SH is a leading risk factor in the development of primary liver cancer. An epidemic of chronic liver disease is anticipated with rising obesity and diabetes rates. Importantly, SH is reversible in its early stages through interventional dietary and lifestyle changes, and control of co-morbidity.\n\nA further significant clinical problem in liver disease is the current inability to accurately assess chemotherapy associated liver damage in patients with secondary liver cancer. This is important for colorectal carcinoma (CRC) patients whose disease has spread to their liver, who receive chemotherapy prior to their liver resection, as chemotherapy associated liver damage can impact morbidity after surgery. Although blood liver function tests give a guide to adverse postoperative liver events, these tend to underestimate chemotherapy associated liver damage. The amount of preoperative chemotherapy which can be safely given, therefore, is arbitrarily limited, and the risk of postoperative complications remains unpredictable. \n\nThere are no non-invasive methods available to diagnose SH in its reversible, pre-fibrotic phase, or to measure chemotherapy associated liver damage. Liver biopsy is currently the only invasive option, however, it carries significant risks, is costly and subject to sampling variations. \n\nThis is a pilot study to assess the feasibilty of conducting PET (positron emission tomography) imaging and novel MR (magnetic resonance) imaging to diagnose SH in its reversible, pre-fibrotic phase, and to measure chemotherapy associated liver damage.
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/1860
Date of REC Opinion
15 Nov 2017
REC opinion
Favourable Opinion