An interventional study of MRI contrast-enhancing agents in HCC - Hepatocellular Carcinoma, TACE and SIRT, sponsored by Université de Montréal. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Université de Montréal · Not applicable, Interventional, and Diagnostic
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.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 60 is above the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Université de Montréal is the lead sponsor of 98 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
a diagnostic test (MRI)
Diagnostic Test: MRI contrast-enhancing agents
MRI before and after treatment
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.
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.
Plan to share: No
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Started Nov 2024 (actual). Primary completion is estimated for Dec 2027, 36 months after the start.
Of 360 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 36 months is below that.
Counting every sponsor, half of 384 studies reached it within 47 months; a quarter within 23 and three quarters within 75.
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Université de Montréal