Dynamic Oxygen-Enhanced (OE) MRI to Predict Treatment Response After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Université de Montréal
- Enrollment
- 60
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Investigators
Audrey Fohlen
Principal investigator, MD, PhD
Centre hospitalier de l'Université de Montréal (CHUM)
