LiverMultiScan Analysis of MRI Scans in HCC

Prior treatment

• Common Exclusion Criteria (Surgical Resection, Y90 Treatment and Systemic Therapy):
• Surgical resection
  • Has encephalopathy.
  • Has received a major organ allograft.
  • Has an uncontrolled bleeding disorder.
  • Has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
  • Has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
  • Has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
• Systemic therapy
  • Receiving concurrent therapy alongside systemic therapy.
  • Has no anti-cancer specific treatment within 4 weeks prior to the initiation of systemic therapy.
  • Has encephalopathy.
  • Has history of allergic disease or reactions likely to be exacerbated by any component of treatment.
  • Has had a solid organ or hematologic transplant. Has clinically apparent ascites on physical examination. Note: Ascites detectable on imaging studies only are allowed.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has current pneumonitis or known history of, or any evidence of active, non-infectious pneumonitis that requires steroids.
  • Has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or any uncontrolled arrhythmia at the time of enrolment into study.
  • Has known psychiatric or addictive disorders that may compromise the patient's ability to give informed consent, or to comply with trial procedures.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
  • Has had a minor surgery ≤7 days prior to the first dose of systemic therapy.

Other illness

• Is unable to return for follow-up visits to monitor for disease response/progression

Lab values

• Has low creatinine clearance (estimated glomerular filtration rates \< 60)

Other

• Is unable to have a MRI scan, including but not limited to claustrophobia, implanted metallic devices and metal foreign bodies
• Non-provision of informed consent
• For female patients: pregnant or lactating
• Y90 treatment
  • o Nil

• Common Inclusion Criteria (Surgical Resection, Y90 Treatment and Systemic Therapy):
• Male and female patients, 21 to 90 years of age at the time of signing of the informed consent form.
• For HCC patients: Diagnosis of HCC confirmed by either 1 of the following 3 criteria:
  • AASLD imaging criteria
  • Histology/cytology of biopsy or surgically resected tumor tissue samples
  • Space occupying lesion in the liver and serum alpha-fetoprotein (AFP) of more than 400 in patients with chronic viral hepatitis or cirrhosis of any cause
• For CM patients: Diagnosis of colorectal cancer with metastasis to the liver confirmed by histology/cytology.
• Has ECOG performance status 0-1 before treatment intervention.
• Surgical Resection
  • Has received no anti-cancer specific treatment for HCC i.e. previous liver resection, loco-regional therapy (e.g. RFA, TACE, SIRT), radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy within 4 weeks prior to the date of the planned surgery.
  • Has adequate bone-marrow reserve, renal function and hepatic function as assessed by standard laboratory criteria:
  • Absolute neutrophil count ≥ 1.0 x 10\^9/L
  • Platelet count ≥ 50 x 10\^9/L
  • Haemoglobin ≥ 9.0 g/dL
  • INR ≤ 2.0
  • Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN)
  • Albumin ≥ 2.5 g/dL
  • Total bilirubin ≤ 1.5 times the ULN
  • Alanine transaminase (ALT) ≤ 2.5 times the ULN
  • Aspartate Transaminase (AST) ≤ 2.5 times the ULN
  • Has Child-Pugh score ≤ 7.
• Y90 treatment
  • Y-90 therapy as the main treatment.
  • Has Child-Pugh score ≤ 7.
• Systemic therapy
  • Systemic therapy as the only treatment.
  • Has Child-Pugh score ≤ 8