Characterizing liver cancer treatment with advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to improve the management of advanced-stage hepatocellular carcinoma (HCC) treated with targeted radionuclide therapy (TARE) by utilizing innovative imaging-based artificial intelligence and simultaneous PET-MRI imaging. The study will create a large prospective cohort of HCC patients to identify predictive markers for TARE effectiveness, focusing on genomic profiling and novel radionuclides. By standardizing clinical, molecular, and imaging data collection, the research seeks to enhance patient selection and treatment efficacy for those undergoing TARE.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with HCC for whom TARE decision was made at the MDT
* Patients ≥ 18 years of age
* Diagnosis of HCC based on imaging (EASL guidelines) and confirmed histologically
* At least one target lesion to be treated by radioembolisation, naïve to any previous treatment
* Child-Pugh Class \< B8
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Life expectancy ≥ 3 months
* Available baseline imaging (multiphasic CT), performed within 6 weeks before the beginning of TARE

Exclusion Criteria:

* Patient with contraindication to MRI
* Patient with contraindication to 18F-choline : potential hypersensitivity to the product or to any excipients
* Non-adequate bone marrow, liver and renal function within 15 days prior to work-up as assessed by the following laboratory tests:

  * Hemoglobin ≤ 8.0 g/Dl
  * Platelet count \< 50,000/ mm3
  * Total bilirubin \> 3 mg/dL (or \> 51 µmol/ L).
  * Prothrombin time ≤ 50%
  * Glomerular Filtration Rate (GFR) \< 35 mL/min/1.73 m2
* Infiltrating tumor more than 70% of the liver
* Prior liver transplantation
* Initial prescription for SIRT and concomitant systemic treatment
* Patient refusal to give written and informed consent
* No affiliation to a social security regimen or CMU
* Patient under State Medical Aid
* Known pregnancy or breastfeeding women
* Patient deprived of freedom, subject under a legal protective measure
* Any significant medical, psychiatric, or surgical condition that is uncontrolled and could endanger the subject's safety or limit adherence to the study's objectives and assessments

Where it's running

• Service de Médecine Nucléaire, Hôpital Beaujon
  Clichy, France Recruiting
• Beaujon hospital
  Clichy, France Recruiting
• Service de Médecine Nucléaire, CHU de Nantes
  Nantes, France Recruiting
• CHU Nantes
  Nantes, France Active not recruiting
• Service de medecine nucleaire, Hôpital Bichat
  Paris, France Active not recruiting

Study contacts

• Principal investigator: Catherine ANSQUER, Dr — Nantes University Hospital
• Study coordinator: Valérie VILGRAIN
• Email: valerie.vilgrain@aphp.fr
• Phone: 00-33-1-40-87-53-58

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.