OE MRI to Predict Treatment Response After TACE in HCC Patients

NCT07617038 | Enrolling By Invitation

• 1 other identifier: 2024-11608,23.284
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC - Hepatocellular Carcinoma; TACE; SIRT

Keywords

Hypoxia; MRI; Oe MRI; Predictive factors

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• 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.

Study Arms (1)

HCC patients

EXPERIMENTAL

a diagnostic test (MRI)

Diagnostic Test: MRI contrast-enhancing agents

Interventions

MRI contrast-enhancing agents DIAGNOSTIC_TEST

MRI before and after treatment

HCC patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• no pulmonary disease
• able to stay 2 hours in MRI

You may not qualify if:

• contraindication for MRI
• contraindication for contrast injection
• claustrophobia

Sponsors & Collaborators

• Laboratory ISTCT UMR6030 CNRS of Caen (France): collaborator
• Université de Montréal: lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

CRCHUM

Montreal, Quebec, H2X0A9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hypoxia

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: June 1, 2026
• Study Start: November 27, 2024
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)