Status:
COMPLETED
LiverMultiScan Analysis of MRI Scans in HCC
Lead Sponsor:
National Cancer Centre, Singapore
Collaborating Sponsors:
Perspectum
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
21-90 years
Brief Summary
This project is a pilot study to interrogate the potential of LMS as a predictive tool for the selection of therapy for HCC patients. The reliability of LMS to predict patients' response following HCC...
Detailed Description
Liver cancer is currently the second most common cause of cancer-related death worldwide, and hepatocellular carcinoma (HCC) accounts for more than 90% of liver cancers. There has been a marked increa...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Inclusion Criteria Specific to Treatment Arm:
- 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
- Exclusion criteria:
- Common Exclusion Criteria (Surgical Resection, Y90 Treatment and Systemic Therapy):
- Has low creatinine clearance (estimated glomerular filtration rates \< 60)
- Is unable to return for follow-up visits to monitor for disease response/progression
- 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
- Exclusion Criteria Specific to Treatment Arm:
- 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.
- Y90 treatment
- o Nil
- 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.
Exclusion
Key Trial Info
Start Date :
October 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04451603
Start Date
October 19 2018
End Date
December 31 2023
Last Update
March 13 2024
Active Locations (1)
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1
National Cancer Center Singapore
Singapore, Singapore, 169690