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New treatment option for Hepatocellular Carcinoma
Official title Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
ClinicalTrials.gov ID: NCT06334965
What this study is testing
- What it's testing
- OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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).
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Clichy, France
- Nantes, France
- Paris, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy, France; Nantes, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.