OE MRI to Predict Treatment Response After TACE in HCC Patients

N/AEnrolling By InvitationNCT07617038

Université de Montréal60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

HCC - Hepatocellular Carcinoma TACE SIRT

Interventions

MRI contrast-enhancing agentsDIAGNOSTIC_TEST

MRI before and after treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * no pulmonary disease * able to stay 2 hours in MRI Exclusion Criteria: * contraindication for MRI * contraindication for contrast injection * claustrophobia

Locations (1)

CRCHUM

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Hypoxic levels of hepatocellular carcinoma according to R1 variations during an oxygen challenge on MRI scans before treatment.

T1 mapping is performed on an MRI during an oxygen challenge. The mean R1 value (equal to 1/T1) is calculated under ambient air conditions and after 15 minutes of inhaling 100% oxygen. The mean delta R1 values (i.e. the changes during the oxygen challenge, such as the difference in R1 values when exposed to 21% and 100% oxygen) are reported for each tumour measuring over 25 mm in each patient. The correlation between the delta R1 values and tumour response will be analysed.

Time frame: Oxygen-enhanced MRI will be performed 4-6 weeks before treatment. Patients will be followed up 2 years after treatment.

Secondary Outcomes

Hypoxic level of HCC according to R1 variations during an oxygen challenge on MRI scans after treatment

After treatment, T1 mapping is performed on an MRI during an oxygen challenge. The mean R1 value (equal to 1/T1) is calculated under ambient air conditions and after 15 minutes of inhaling 100% oxygen. The mean delta R1 values (i.e., the changes during the oxygen challenge, such as the difference in R1 values between exposures to 21% and 100% oxygen) are reported for each targeted tumour in each patient. The correlation between the delta R1 values after treatment and tumour response will be analysed.

Time frame: Oxygen-enhanced MRI is performed 4-6 weeks after treatment. Patients are followed up 2 years after treatment.

Data from ClinicalTrials.gov

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