Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort (OPERANDI-HCC)

March 21, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Clichy, France
        • Beaujon Hospital
        • Contact:
          • Mohamed BOUATTOUR
      • Nantes, France
        • CHU Nantes
        • Contact:
          • Yann Touchefeu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET-MRI
PET-MRI added in care pathway
Other: Simultaneous 18F-Choline PET-MRI
before first TARE administration (after work-up procedure) and one month after TARE administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: 12 months after the day of first administration of TARE
Clinical response defined by the PFS as the time measured from the day of first administration of TARE to first progression or death at 12 months, whichever occurs first
12 months after the day of first administration of TARE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Catherine ANSQUER, Dr, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230279

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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