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Trial Title:
Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
NCT ID:
NCT06334965
Condition:
Hepatocellular Carcinoma
Radioembolization
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Choline
Conditions: Keywords:
transarterial radioembolization
18F Choline PET-MRI
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Simultaneous 18F-Choline PET-MRI
Description:
before first TARE administration (after work-up procedure) and one month after TARE
administration
Arm group label:
PET-MRI
Summary:
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 and follow-up PET-MRI, in patients with HCC
treated with TARE.
Detailed description:
Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumors,
considered the sixth most common cancer and the third major cause of cancer-related
death. Its worldwide incidence is expected to increase in the future. Additionally, it
shows marked intertumor and intratumor heterogeneity at the microscopic and molecular
levels, and there are currently no reliable imaging markers for predicting response to
TARE.
TARE is a highly advanced treatment that consists in intra-arterial injection of
radioactive microspheres. TARE is already approved for liver metastases and HCC in most
countries. So, TARE for HCC, is part of the therapeutic Armamentarium exerting antitumor
effects based on radio-biological (DNA damage) and immunological mechanisms. TARE using
most currently 90Y-loaded microspheres has proven its non-inferiority with better
tolerance and better tumor response in comparison with systemic treatments in patients
with HCC.
While highly promising, patient stratification and early identification of responders are
currently insufficient due to the lack of pertinent imaging biomarkers, either
non-invasive or invasive. Furthermore, prior therapy-induced DNA damages may lead to
tumor resistance, therefore reducing TARE efficacy. Hence, the absence of a personalized
treatment strategy is an unmet need for patients with HCC. This may result in survival
disadvantage for non-responders, who could benefit otherwise from early treatment change,
with expected more favorable outcomes.
Simultaneous PET-MRI: OPERANDI proposes a completely innovative and holistic approach via
PET-MRI guided therapy. The research hypothesis is that simultaneous PET-MRI imaging
provides more robust non-invasive predictive biomarkers than classical approach and
better correlation between quantification of radiation therapy dosimetry and clinical
outcomes than PET-CT. This requires technological development of PET-MRI, with most
methodological challenges being attenuation correction, reducing the impact of organ
motion due to respiration and cardiac motion, and minimizing truncation and
susceptibility artifacts.
A PET/MRI scan is a two-in-one test that combines images from a positron emission
tomography (PET) scan and a magnetic resonance imaging (MRI) scan. This new hybrid
technology harnesses the strengths of PET and MRI to produce some of the most highly
detailed images currently available. MRI scans use a strong (1.5 to 3T for clinical use)
magnetic field to produce detailed morphologic images and some sequences provide
functioning information (such as diffusion-weighted, dynamic contrast-enhanced, MR
elastography sequence). PET scans use tracers according to the clinical indications to
highlight metabolism changes. In HCC, the most common radiotracers are fluorodeoxyglucose
(FDG) or Choline, which detect metabolically active malignant lesions.
OPERANDI project aims to address unmet clinical needs in the current management of 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). Investigators 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 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 and follow-up PET-MRI, in patients with HCC
treated with TARE.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with HCC for whom TARE decision was made at the MDT
- Male or female patients ≥ 18 years of age
- Diagnosis of HCC based on imaging (EASL guidelines) and confirmed histologically
- Liver function status Child-Pugh Class < B8
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Adequate bone marrow, liver and renal function as assessed by the following
laboratory tests:
1. Hemoglobin > 8.0 g/Dl
2. Platelet count ≥ 50,000/ mm3
3. Total bilirubin ≤ 3 mg/dL (or ≤ 51 µmol/ L).
4. Prothrombin time > 50%
5. Glomerular Filtration Rate (GFR) ≥ 35 mL/min/1.73 m2
- Life expectancy ≥ 3 months
- Available baseline imaging (multiphasic CT), performed within 6 weeks before the
beginning of TARE
- Patients who have signed a consent form to participate in the study, obtained prior
to the start of any protocol related activities
Exclusion Criteria:
- Patients with contraindication to MRI
- Contraindication to 18F-choline : potential hypersensitivity to the product or to
any excipients
- Patient with severe renal insufficiency
- Multilobular infiltrating tumor more than 70% of the liver
- Prior liver transplantation
- Child-Pugh B9 and C
- Previously treated by surgery or chemo embolization
- Absence of written informed consent from the patient under guardianship or
trusteeship
- No affiliation to social security (beneficiary or assignee) (as Patient on AME
(state medical aid))
- Known pregnancy or breastfeeding women
- For women of childbearing age, positive pregnancy test (blood or urine)
- Person deprived of liberty and / or person under psychiatric care
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beaujon hospital
Address:
City:
Clichy
Country:
France
Contact:
Last name:
Mohamed BOUATTOUR
Facility:
Name:
CHU Nantes
Address:
City:
Nantes
Country:
France
Contact:
Last name:
Yann TOUCHEFEU
Start date:
March 2024
Completion date:
September 2029
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06334965