HCC - Hepatocellular Carcinoma, SIRT, TACE
Conditions
Keywords
Hypoxia, MRI, Oe MRI, Predictive factors
Brief summary
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTMRI contrast-enhancing agents
MRI before and after treatment
Sponsors
Université de Montréal
Laboratory ISTCT UMR6030 CNRS of Caen (France)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* no pulmonary disease * able to stay 2 hours in MRI
Exclusion criteria
* contraindication for MRI * contraindication for contrast injection * claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxic levels of hepatocellular carcinoma according to R1 variations during an oxygen challenge on MRI scans before treatment. | Oxygen-enhanced MRI will be performed 4-6 weeks before treatment. Patients will be followed up 2 years 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxic level of HCC according to R1 variations during an oxygen challenge on MRI scans after treatment | Oxygen-enhanced MRI is performed 4-6 weeks after treatment. Patients are followed up 2 years 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. |
Countries
Canada
Outcome results
None listed