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Early detection of hepatocellular carcinoma by Hyperpolarized [1-13C]pyruvate MRI

Phase 1
Conditions
Primary liver cancer
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Registration Number
CTIS2024-512490-27-00
Lead Sponsor
Aarhus Universitet
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
46
Inclusion Criteria

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, 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.

Exclusion Criteria

-Chronic kidney disease, •Contraindications for MRI with contrast:, •Competing systemic disease (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, -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), -Largest circumference including arms > 160 cm, -Claustrophobia

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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