The CLiFF Study: Change in Liver Function & Fat in pre-op chemotherapy

  • Research type

    Research Study

  • Full title

    The CLiFF Study: A prospective evaluation of Change in Liver Function and Fat in patients with colorectal liver metastases undergoing pre-operative chemotherapy

  • IRAS ID

    248694

  • Contact name

    Andrew Renehan

  • Contact email

    andrew.renehan@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • Clinicaltrials.gov Identifier

    NCT03562234

  • Duration of Study in the UK

    1 years, 7 months, 1 days

  • Research summary

    Title:

    The CLiFF Study: Change in Liver Function and Fat during pre-operative chemotherapy for CLM.

    Research Question:

    The CLiFF Study will assess changes in liver function and liver fat following chemotherapy for CLM (colorectal liver metastases - bowel cancer deposits in the liver).

    Relevance:

    Obesity is the second commonest cause of cancer in the UK and bowel cancer is the commonest cancer. Obesity can increase both the chance of developing bowel cancer and it’s progression. Increased liver fat is likely to be important in this process, but it is not easy to measure liver fat accurately without invasive biopsies.

    Chemotherapy is often used to treat CLM before surgery. Chemotherapy can increase liver fat and can reduce liver function, however it is not known if these changes are either reversible or related.

    Understanding the relationship of these changes and their potential reversibility could help plan the best CLM treatment and to understand the relationship between obesity and cancer.

    Methods:

    Our cancer research team have developed new MR (magnetic resonance) scan techniques which are better able to measure liver fat levels without needing invasive biopsies. We also have a newly-developed fully-licensed machine which can measure liver function more accurately by using a breath test (LiMAx test), donated to the team for this study.

    Patients undergoing pre-operative chemotherapy for CLM at the Christie Hospital will be invited to join this study. Their liver fat content will be measured using the new MR techniques and their liver function measured using the LiMAx test. These will be measured before chemotherapy, during chemotherapy, and after they finish. Their normal treatment will remain unchanged. After they undergo liver surgery, the report issued on the fat content of the removed liver will be compared with the MR scan to help us check that the scans are accurate.

  • REC name

    North West - Preston Research Ethics Committee

  • REC reference

    18/NW/0531

  • Date of REC Opinion

    22 Aug 2018

  • REC opinion

    Further Information Favourable Opinion