NCT03562234

The CLiFF Study: Change in Liver Function and Fat in Pre-operative Chemotherapy for Colorectal Liver Metastases

The CLiFF Study: A Prospective Evaluation of Change in Liver Function and Fat in Patients With Colorectal Liver Metastases Undergoing Pre-operative Chemotherapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 35 (estimated)
• Sponsor: University of Manchester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CLiFF Study will assess changes in liver function and liver fat in patients with colorectal liver metastases (CLM) undergoing pre-operative chemotherapy before liver resection. There will be no change to the standard treatment for CLM. The change in liver fat will be assessed using novel magnetic resonance techniques and the change in liver function will be measured using a newly-developed fully-licensed breath test to give the most accurate measure of liver function possible. Understanding if these changes are related or reversible will help to understand the relationship between obesity and cancer. This is an important issue, as obesity is now the second most common cause of cancer worldwide.

Detailed description

Obesity is the second most common cause of cancer in the United Kingdom (UK) and bowel cancer is the third most common 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 colorectal liver metastases before surgery. It is known that 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 treatment for colorectal liver metastases and to understand the wider relationship between obesity and cancer. A Manchester cancer research team have developed new MR (magnetic resonance) scan techniques which are better able to measure liver fat levels without needing invasive biopsies. The researchers 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 by the manufacturer, Humedics GmbH. 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. When they undergo liver surgery, the section of removed liver will be analysed for fatty changes to help confirm that the MR scans are accurate.

Conditions

• Colorectal Cancer
• Liver Metastasis Colon Cancer
• Chemotherapy Effect
• Obesity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MR	Liver fat (measured as a percentage - hepatic fat fraction) will be measured by Magnetic Resonance imaging
DIAGNOSTIC_TEST	LiMAx	Liver function will be measured using the relatively new CE licenced non-invasive LiMAx (Liver Maximum Capacity) test device, manufactured by Humedics GmbH

Timeline

• Start date: 2018-10-22
• Primary completion: 2020-02-01
• Completion: 2020-04-01
• First posted: 2018-06-19
• Last updated: 2018-11-07

Locations

1 site across 1 country: United Kingdom