An assessment of the natural progression of drug associated changes in liver fat levels following completion of chemotherapy for deposits of cancer in the liver which have spread from the large bowel

An assessment of the natural progression of iatrogenic changes in intra-hepatic fat levels following cessation of neoadjuvant chemotherapy for colorectal liver metastases

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14012920

Enrollment

Registered

2016-07-01

Start date

2016-06-01

Completion date

Unknown

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic steatosis/intra-hepatic fat in patients with colorectal liver metastases who are undergoing neoadjuvant chemotherapy Digestive System

Interventions

30 patients in receipt of neoadjuvant chemotherapy for metachronous colorectal liver metastases will be asked to attend Royal Blackburn Hospital on 2 occassions. During first visit, a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent. 2. Patients in receipt of neoadjuvant chemotherapy for CRLM. 3. Persons over 18 years old

Exclusion criteria

Exclusion criteria: 1. Persons under 18 years of age. 2. Conditions in which the supine position and breath holds required for MR scanning are not possible. 3. Persons who might not adequately understand verbal explanations or written information given in English, or who have special communication needs. 4. Persons with contraindications to MR imaging- presence of cardiac pacemaker/artificial heart valve/aneurysm clips/metallic fragments in eyes/cochlear implants 5. Pre-existing chronic liver pathology such as haemachromatosis, viral hepatitis or primary hepatic malignancy.

Design outcomes

Primary

Measure	Time frame
Intrahepatic fat fraction as measured by 2 Chemical Shift Magnetic Resonance scans greater than 24 hours apart.	—

Secondary

Measure	Time frame
1. Indocyanine Green Plasma Disappearance Rate and Retention at 15 minutes, measured using a PULSiON Indocyanine Green Clearance Testing Device. This will be measured at visit 1 (Week 0 - at cessation of chemotherapy) and 4 weeks later (pre-operatively) 2. BMI, Height, Weight and Hip to Waist ratio, measured at visit 1 (Week 0 - at cessation of chemotherapy) and 4 weeks later (pre-operatively) 3. Assessment of Liver function, Glycaemic control and Lipid profile, including Bilirubin, AST, ALT, ALP GGT, HbA1c, Random Glucose, Triglycerides and Cholesterol at visit 1 and 2	—

Measure

Time frame

1. Indocyanine Green Plasma Disappearance Rate and Retention at 15 minutes, measured using a PULSiON Indocyanine Green Clearance Testing Device. This will be measured at visit 1 (Week 0 - at cessation of chemotherapy) and 4 weeks later (pre-operatively) 2. BMI, Height, Weight and Hip to Waist ratio, measured at visit 1 (Week 0 - at cessation of chemotherapy) and 4 weeks later (pre-operatively) 3. Assessment of Liver function, Glycaemic control and Lipid profile, including Bilirubin, AST, ALT, ALP GGT, HbA1c, Random Glucose, Triglycerides and Cholesterol at visit 1 and 2

—

Countries

United Kingdom

Contacts

Public ContactLinda Gregson

linda.gregson@elht.nhs.uk01254 263555

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026