NCT06334965Recruiting
Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
Source: ClinicalTrials.gov · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI. Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic PET-MRI, in patients with HCC treated with TARE.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 5 Feb 2024
- Start date
- Jul 2024
- Primary completion date
- Nov 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06334965
What you commit to
- Study type: Interventional
- Planned participants: 180
- From Jul 2024 to the primary completion date, Nov 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior liver transplantation
- Initial prescription for SIRT and concomitant systemic treatment
Other illness
- Patient with contraindication to 18F-choline : potential hypersensitivity to the product or to any excipients
- 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
Lab values
- 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
Other
- Patient with contraindication to MRI
- Infiltrating tumor more than 70% of the liver
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beaujon Hospital Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Service de Médecine Nucléaire, Hôpital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Service de Médecine Nucléaire, CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Service de medecine nucleaire, Hôpital Bichat Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.