Early diagnosis of liver cancer with metabolic MRI

Phase 1

Conditions: Primary liver cancer
MedDRA version: 21.0Level: LLTClassification code 10036706Term: Primary liver cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Registration Number: EUCTR2021-000863-56-DK

Lead Sponsor: Aarhus University, The MR Research Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 46

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.