OE MRI to Predict Treatment Response After TACE in HCC Patients (HERO)

Université de Montréal

Status: Invitation-only

Conditions: SIRT; HCC - Hepatocellular Carcinoma; TACE

Treatments: Diagnostic Test: MRI contrast-enhancing agents

Study type: Interventional

Funder types: Other

Identifiers

NCT07617038

2024-11608,23.284

Details and patient eligibility

About

To predict response of HCC to TACE using dynamic oxygen-enhanced (dOE)-MRI for assessment of the level of tumor hypoxia before and after treatment.

Full description

This will be a single-center, prospective, study to evaluate dOE-MRI in patients undergoing TACE for HCC according to the clinical standard of care. This protocol has already been approved by the local research ethics committee. Adult patients with HCC >25mm undergoing TACE are enrolled. Imaging will be performed on a 3T whole-body MRI, dOE-MRI will be acquired with a free-breathing T1-weighted dynamic acquisition with respiratory motion-resolved compressed sensing reconstruction (XD-GRASP). Tumor hypoxia will be assessed by measuring changes in the longitudinal relaxation rate (∆R1) from baseline (21% O2) and during a hyperoxic respiratory challenge (FiO2 100%). Tumor response will be assessed by mRECIST and LI-RADS Treatment Response Assessment v2024. Descriptive statistics for the level of ∆R1 pre- and post- treatment will be presented using means and standard deviations. Progression-free survival and overall survival will be evaluated by using the Cox proportional hazard model and Kaplan-Meier method. Receiver operating characteristic (ROC) curve analysis at one year will be performed and the optimal cutoff threshold of ∆R1 will be calculated using Youden's index.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• no pulmonary disease
• able to stay 2 hours in MRI

Exclusion criteria

• contraindication for MRI
• contraindication for contrast injection
• claustrophobia

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

HCC patients

Experimental group

Description:

a diagnostic test (MRI)

Treatment:

Diagnostic Test: MRI contrast-enhancing agents