Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LiMAx | Diagnostic Test | — | UNRESOLVED |
| MR | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pre-op Chemotherapy for CLM: MR & LiMAx
- description
- Patients undergoing pre-operative chemotherapy for colorectal liver metastases being treated at the Christie NHS (National Health Service) Foundation Trust. No intervention - participants will continue with standard care. Observation of changes in liver fat and liver function measured by MR (Magnetic Resonance) scan and LiMAx test (Maximum liver capacity).
- interventionNames
- Diagnostic Test: MR
- Diagnostic Test: LiMAx
Primary outcomes (2)
- measure
- Change in liver fat (hepatic fat fraction)
- timeFrame
- 21 weeks
- description
- Change in liver fat (measured as a percentage using MR imaging - the hepatic fat fraction) comparing the baseline pre-chemotherapy measurement at Week 1 with measurements at cessation of chemotherapy (Week 13) and 8 weeks after cessation of chemotherapy (Week 21). The expectation based on relevant literature is that chemotherapy will lead to potentially reversible higher levels of liver fat. Therefore the liver fat measurement (hepatic fat fraction) should be higher at week 13 than at week 1, and if this change is reversible, the liver fat should decrease during the eight weeks following cessation of chemotherapy, resulting in the measurement at Week 21 being lower than week 13.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically verified adenocarcinoma of the colon or rectum with radiological evidence of potentially resectable liver metastases, with no evidence of unresectable non-hepatic metastatic disease. 2. Pre-operative chemotherapy planned using Oxaliplatin-based chemotherapy regimen (including FOLFOX, XELOX and OXCAP regimens 3. Age greater than or equal to 18 years 4. WHO (World Health Organisation) performance status 0, 1 or 2 5. Adequate haematological and hepatic function defined by: Hb ³ 10g/dl, WBC ³ 3.0 x 109/L, ANC ³ 1.5 x 109/L, platelet count ³ 100,000/ mm3, total bilirubin \< 30 mmol/L, serum AST, ALT and alkaline phosphatase 5 x upper limit of normal 6. Renal function with creatinine clearance 60 mls/min (for full dose) or 30 ml/min for 50%-dose oxaliplatin 7. Patients must have given written informed consent 8. Any woman of childbearing potential must have a negative pregnancy test prior to enrolment in to the study and must take adequate precautions to prevent pregnancy during treatment Exclusion Criteria: 1. Presence of a medical or psychiatric condition that impairs their ability to give informed consent 2. Presence of any other serious uncontrolled medical conditions 3. Evidence of unresectable non-hepatic metastatic disease 4. Pregnant or lactating women. Adequate contraception must be used in fertile patients 5. Contra-indications to MR scanning
References
Publications (1)
- DERIVEDParmar KL, O'Reilly D, Valle JW, Braun M, Naish JH, Williams SR, Lloyd WK, Malcomson L, Cresswell K, Bamford C, Renehan AG. Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study. BMJ Open. 2020 Sep 23;10(9):e027630. doi: 10.1136/bmjopen-2018-027630. PMID 32967864