Primary liver cancer MedDRA version: 21.0 Level: LLT Classification code 10036706 Term: Primary liver cancer non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Aarhus University, The MR Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • All participants: - Aged 18 – 85 years. The age and gender of the healthy controls of the main study will be matched to the participating patients. - Pre-menopausal women must be confirmed non-pregnant by an onsite test • HCC group: - Diagnosed HCC larger than 10 mm confirmed by standard MRI, or CT or confirmed by tumour biopsy. - Subgroup 1: Not elected for liver surgery - Subgroup 2: Elected for liver surgery • Small tumor group: - One or more small lesions in the liver requiring 2 years of repeated follow-up as per the EASL guideline. Could be in a liver with a confirmed HCC. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: • Contraindications for MRI with contrast: - Chronic kidney disease - Patients with tumors must have eGFR > 30 ml/min/1.73m2 - Significant cardiac disease (as left ventricular outflow obstruction or heart failure) - Significant obstructive lung disease or severe asthma - Pacemaker, neurostimulator or cholera implant - Metal foreign bodies such as fragments and irremovable piercings - Unsafe medical implants (safety of heart valves, hips and the like must be confirmed) - Claustrophobia - Largest circumference including arms > 160 cm • Competing systemic disease including diabetes (hypertension, dyslipidemia, diabetes etc. allowed) • Hepatic encephalopathy = grade 2. • Stents or other devices implanted close to the liver that may cause imaging artefacts • Allergy to pyruvate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This project seeks to determine the potential of hyperpolarized pyruvate MRI in early characterization of primary liver cancer - particularly small tumors. ;Secondary Objective: Not applicable;Primary end point(s): Liver metabolism as assessed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine.;Timepoint(s) of evaluation of this end point: After the scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease characterization from clinical examination, interviews and patient records. For the group of patients with small tumours, a clinical two year follow-up is required for a final diagnosis. ;Timepoint(s) of evaluation of this end point: After the scan and up to two years after. | — |
Countries
Denmark
Contacts
Public ContactThe MR Research Center
Aarhus University
Outcome results
None listed