PYRUVIC ACID for Hepatocellular carcinoma | Primary liver cancer

Inclusion criteria

• {"criterion_text":"- -\tAged 18 – 85 years. The age and gender of the healthy controls of the main study will be matched to the participating patients."}
• {"criterion_text":"- -\tPre-menopausal women must be confirmed non-pregnant by an onsite test"}
• {"criterion_text":"- •\tHCC group: -\tDiagnosed HCC larger than 10 mm confirmed by standard MRI, CT or confirmed by tumour biopsy. -\tSubgroup 1: Not elected for liver surgery -\tSubgroup 2: Elected for liver surgery"}
• {"criterion_text":"- •\tSmall tumor group: -\tOne 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."}

Exclusion criteria

• {"criterion_text":"- -\tChronic kidney disease"}
• {"criterion_text":"- •\tContraindications for MRI with contrast:"}
• {"criterion_text":"- •\tCompeting systemic disease (hypertension, dyslipidemia, diabetes etc. allowed)"}
• {"criterion_text":"- •\tHepatic encephalopathy ≥ grade 2."}
• {"criterion_text":"- •\tStents or other devices implanted close to the liver that may cause imaging artefacts"}
• {"criterion_text":"- •\tAllergy to pyruvate"}
• {"criterion_text":"- -\tPatients with tumors must have eGFR > 30 ml/min/1.73m2"}
• {"criterion_text":"- -\tSignificant cardiac disease (as left ventricular outflow obstruction or heart failure)"}
• {"criterion_text":"- -\tSignificant obstructive lung disease or severe asthma"}
• {"criterion_text":"- -\tPacemaker, neurostimulator or cholera implant"}
• {"criterion_text":"- -\tMetal foreign bodies such as fragments and irremovable piercings"}
• {"criterion_text":"- -\tUnsafe medical implants (safety of heart valves, hips and the like must be confirmed)"}
• {"criterion_text":"- -\tLargest circumference including arms > 160 cm"}
• {"criterion_text":"- -\tClaustrophobia"}

Primary endpoints

• {"endpoint_text":"- The raw data will be processed using both model-free and kinetic modeling approaches, which are the standards of analyzing hyperpolarized pyruvate MRI data, to quantify metabolism and perfusion.","definition_or_measurement_approach":"Processing raw hyperpolarized pyruvate MRI data using both model-free and kinetic modelling approaches to quantify metabolism and perfusion (as stated)."}

Denmark

Earliest CTIS Part Ii Submission Date

12-07-2024

Latest Decision Or Authorization Date

25-07-2024

Processing Time Days

13

Number Of Sites

1

Number Of Participants

46

Primary sponsor

Full Name

Aarhus Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"1","organisation_type":"Educational Institution"}