HCC - Hepatocellular CarcinomaHERONCT07617038
OE MRI to Predict Treatment Response After TACE in HCC Patients
A study testing MRI contrast-enhancing agents in people with HCC - Hepatocellular Carcinoma and TACE, run by Université de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, TACE, SIRT
- What is being tested?
- MRI contrast-enhancing agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2024to 20 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no pulmonary disease
- able to stay 2 hours in MRI
Who cannot join
- contraindication for MRI
- contraindication for contrast injection
- claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dynamic Oxygen-Enhanced (OE) MRI to Predict Treatment Response After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients
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.
Read the 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.
- Conditions
- HCC - Hepatocellular Carcinoma, TACE, SIRT
- Being tested
- MRI contrast-enhancing agents
- Keywords
- Hypoxia, MRI, Oe MRI, Predictive factors
- Medical subject headings
- Carcinoma, Hepatocellular, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI contrast-enhancing agentsDiagnostic test
MRI before and after treatment
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | Experimental | a diagnostic test (MRI) Receives: Diagnostic Test: MRI contrast-enhancing agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Oxygen-enhanced MRI is performed 4-6 weeks after treatment. Patients are followed up 2 years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start27 Nov 2024
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory ISTCT UMR6030 CNRS of Caen (France), Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Principal investigator, Audrey Fohlen, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617038
- Sponsor's protocol ID
- 2024-11608,23.284
- Acronym
- HERO
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Oxygen-Enhanced (OE) MRI to Predict Treatment Response After Transarterial Chemoembolization in Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT07617038
- Acronym / sponsor ID
- HERO / 2024-11608,23.284
- Conditions
- HCC - Hepatocellular Carcinoma, TACE, SIRT
- Keywords
- Hypoxia, MRI, Oe MRI, Predictive factors
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Laboratory ISTCT UMR6030 CNRS of Caen (France), Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients | Experimental | Diagnostic Test: MRI contrast-enhancing agentsa diagnostic test (MRI) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- no pulmonary disease
- able to stay 2 hours in MRI
Key exclusion criteria (3 listed)
- contraindication for MRI
- contraindication for contrast injection
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI contrast-enhancing agentsMRI before and after treatment | Diagnostic test | HCC patients |
Primary outcome
Hypoxic levels of hepatocellular carcinoma according to R1 variations during an oxygen challenge on MRI scans before treatment.
Time frame: 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.
1 secondary outcome
Hypoxic level of HCC according to R1 variations during an oxygen challenge on MRI scans after treatment
Time frame: Oxygen-enhanced MRI is performed 4-6 weeks after treatment. Patients are followed up 2 years after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI contrast-enhancing agents in people with HCC - Hepatocellular Carcinoma and TACE, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxic levels of hepatocellular carcinoma according to R1 variations during an oxygen challenge on MRI scans before treatment. (time frame: Oxygen-enhanced MRI will be performed 4-6 weeks before treatment. Patients will be followed up 2 years after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.