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Clinical Trials/NCT07617038
NCT07617038Enrolling By InvitationNot Applicable

Dynamic Oxygen-Enhanced (OE) MRI to Predict Treatment Response After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients

Université de Montréal1 site in 1 country60 target enrollmentStarted: November 27, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Audrey Fohlen

Principal investigator, MD, PhD

Centre hospitalier de l'Université de Montréal (CHUM)

Study Sites (1)

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