Authorised Therapeutic exploratory (Phase II) Primary liver cancer

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

EU CTIS ID: 2024-512490-27-00

What this study is testing

This project seeks to determine the potential of hyperpolarized pyruvate MRI in early characterization of primary liver cancer - particularly small tumors.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - 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.

You likely can't join if

  • - 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
See the full eligibility criteria
Who can join
  • - 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.
What rules you out
  • - 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.