NCT06334965

Brief 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 PET-MRI, in patients with HCC treated with TARE.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
40mo left

Started Jul 2024

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jul 2024Sep 2029

First Submitted

Initial submission to the registry

February 5, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

July 18, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

January 22, 2025

Status Verified

March 1, 2024

Enrollment Period

3.3 years

First QC Date

February 5, 2024

Last Update Submit

January 20, 2025

Conditions

Hepatocellular CarcinomaRadioembolization

Keywords

transarterial radioembolization18F Choline PET-MRI

Outcome Measures

Primary Outcomes (1)

  • Clinical response

    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

Study Arms (1)

PET-MRI

EXPERIMENTAL

PET-MRI added in care pathway

Other: Simultaneous 18F-Choline PET-MRI

Interventions

Simultaneous 18F-Choline PET-MRIOTHER

before first TARE administration (after work-up procedure) and one month after TARE administration

PET-MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Life expectancy ≥ 3 months
  • Available baseline imaging (multiphasic CT), performed within 6 weeks before the beginning of TARE

You may not qualify 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).
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Service de Médecine Nucléaire, Hôpital Beaujon

Clichy, 92110, France

RECRUITING

Beaujon hospital

Clichy, France

RECRUITING

CHU Nantes

Nantes, France

ACTIVE NOT RECRUITING

Service de Médecine Nucléaire, CHU de Nantes

Nantes, France

RECRUITING

Service de medecine nucleaire, Hôpital Bichat

Paris, 75018, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Catherine ANSQUER, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie VILGRAIN

CONTACT

00-33-1-40-87-53-58valerie.vilgrain@aphp.fr

Françoise KRAEBER - BODERE

CONTACT

00-33-2-40-08-41-45francoise.bodere@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

March 28, 2024

Study Start

July 18, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

September 1, 2029

Last Updated

January 22, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)