Carcinoma, HepatocellularDCE-MRINCT02878109
DCE-MRI for Assessment of Response to TACE of HCC
An observational study of Carcinoma, Hepatocellular, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This study is conducted to evaluate dynamic contrast-enhanced MRI to quantify the efficacy of trans-arterial chemoembolization by comparing imaging results before and after treatment for at least one hepatic tumor and to look at blow flow curves of the free-breathing MRI before treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Post-treatment phase group and Pre-treatment phase group
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population is adults with a hepatocellular carcinoma (HCC). The post-treatment phase group will also encompass patients with a planned transarterial chemoembolization (TACE). For the purpose of this study, the investigators will recruit patients who will be treated at the CHUM.
Who may be able to join
- All patients:
- Are at least 18 years old at screening;
- Able to comprehend and willingness to provide voluntary consent;
- Have at least one HCC;
- HCC lesion of at least 10 mm;
- Understand French or English instruction.
Show all 13Show fewer
- Post-treament phase group:
- Are able to have a MRI before and after TACE;
- Must undergo a TACE as part of their clinical standard of care for HCC;
- Have a new prescription for TACE for at least one HCC.
- Pre-treatment phase group:
- Are able to have a MRI before treatment (if any);
- Must undergo an MRI as part of their clinical standard of care for HCC.
Who cannot join
- Have any contra-indication for MRI (such as claustrophobia, pacemaker, metallic clips for a neurosurgical procedure);
- Are pregnant or trying to become pregnant;
- Have a weight or girth preventing them from entering the MR magnet bore;
- Are unable to understand or unwilling to provide written informed consent for this study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
About this study
Official title: Dynamic Contrast-enhanced Magnetic Resonance Imaging for Assessment of Response to Transarterial Chemoembolization of Hepatocellular Carcinoma
This study is conducted to evaluate dynamic contrast-enhanced MRI to quantify the efficacy of trans-arterial chemoembolization by comparing imaging results before and after treatment for at least one hepatic tumor and to look at blow flow curves of the free-breathing MRI before treatment.
Read the detailed description
Background: Liver cancer is the second leading cause of cancer deaths worldwide. Hepatocellular carcinoma (HCC) typically presents arterial phase hyperenhancement. For intermediate stage disease and the majority of patients not eligible for curative therapies, transarterial chemoembolization (TACE) is considered as the first-line palliative treatment in eligible patients.
Despite its efficacy on HCC, TACE presents major challenges such as the lack of quantitative biomarkers of treatment response. Dynamic contrast-enhanced MRI (DCE-MRI) enables quantitative assessment of tumor and tissue enhancement, by acquiring MR signal intensity as a function of time.
Objectives: This study is conducted: 1) to develop a monitoring system based on quantifiable measures during intra-arterial treatments from dynamic MRI, using time-activity curves analyzed using a dual-input dual-compartment model, and 2) to look at blood flow curves of the MRI before the treatment, if any, for at least one tumor, without requiring any breath hold.
Design:
- Post-treatment phase group: This will be a prospective study in HCC patients undergoing TACE (including DC beads) according to their clinical standard of care. A 4D-THRIVE sequence will be performed. Single intensities before/after gadolinium-based contrast agent enhancement will be used to create time-concentration curves, which will be fitted to a simple perfusion model that accounts for the dual blood supply of the liver through the hepatic artery and the portal vein. Perfusion parameters of arterial hepatic blood flow, portal venous hepatic blood flow, total hepatic blood flow and arterial fraction will be extracted from the model and compared between HCC and surrounding cirrhotic liver. When deemed necessary, a CBCT can be acquired before chemo-embolization in way to see that the appropriate artery is selected for the treatment. The CBCT will be used when available to determine the parameters of the blood flow obtained with our model.
- Pre-treatment phase group: This will be a prospective study in HCC patients undergoing a MRI according to their clinical standard of care. A 4D-THRIVE sequence will be performed. Single intensities before/after gadolinium-based contrast agent enhancement will be used to create time-concentration curves, which will be fitted to a simple perfusion model that accounts for the dual blood supply of the liver through the hepatic artery and the portal vein. Perfusion parameters of arterial hepatic blood flow, portal venous hepatic blood flow, total hepatic blood flow and arterial fraction will be extracted from the model and compared between HCC and surrounding cirrhotic liver.
- Comparison: A comparison between the blood flow curves between the post-treatment phase group [apnea] and the pre-treatment phase group [free-breathing] will be done.
Methods: Forty patients will be selected. For twenty-nine of them [post-treatment phase group], a 4D-THRIVE sequence will be acquired within 2 weeks prior to TACE and between 6 and 8 weeks after TACE. A 4D-FLOW MRI sequence will also be included. For the remaining eleven patients [pre-treatment phase group], only a 4D-THRIVE sequence will be acquired within 2 weeks prior to treatment, if any, including a 4D-FLOW MRI sequence.
Expected results: The results of this study will provide quantitative DCE-MRI biomarkers for identification of viable tumor and tumor response. In addition, presence of increased % arterial flow and decreased portal venous flow in HCC using DCE-MRI are expected to help to assess treatment response.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Post-treatment phase group, Pre-treatment phase group
- Keywords
- Magnetic resonance imaging (MRI), Transarterial chemoembolization (TACE)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-treatment phase groupDevice
4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI)
Pre-treatment phase groupDevice
4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI)
| Study group | Role | What they receive |
|---|---|---|
| Post-treatment phase group | 29 patients will undergo: 4D-THRIVE and 4D-FLOW sequences during magnetic resonance imaging (MRI) before and after transarterial chemoembolisation (TACE). Receives: Device: Post-treatment phase group | |
| Pre-treatment phase group | 11 patients will undergo: 4D-THRIVE and 4D-FLOW sequences during magnetic resonance imaging (MRI) before treatment (if any). Receives: Device: Pre-treatment phase group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic and tumor blood flow before and after TACE
Measures of hepatic and tumor blood flow will help in describing HCC angiogenesis and in determining the efficiency of TACE on the tumor.
Measured: Within 2 weeks before TACE and 6 to 8 weeks after TACE
Hepatic and tumor blood flow before HCC treatment
Measures of hepatic and tumor blood flow will help in describing HCC angiogenesis
Measured: Within 2 weeks before HCC treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Sponsor
- Investigators
- An Tang, MD, MSc, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878109
- Sponsor's protocol ID
- CE15.388
- Acronym
- DCE-MRI
- Status last verified
- Jan 2018
- First submitted
- 22 Aug 2016
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Contrast-enhanced Magnetic Resonance Imaging for Assessment of Response to Transarterial Chemoembolization of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02878109
- Acronym / sponsor ID
- DCE-MRI / CE15.388
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Magnetic resonance imaging (MRI), Transarterial chemoembolization (TACE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Aug 2016 (estimated)
- 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.
This study is conducted to evaluate dynamic contrast-enhanced MRI to quantify the efficacy of trans-arterial chemoembolization by comparing imaging results before and after treatment for at least one hepatic tumor and to look at blow flow curves of the free-breathing MRI before treatment.
Detailed description
Background: Liver cancer is the second leading cause of cancer deaths worldwide. Hepatocellular carcinoma (HCC) typically presents arterial phase hyperenhancement. For intermediate stage disease and the majority of patients not eligible for curative therapies, transarterial chemoembolization (TACE) is considered as the first-line palliative treatment in eligible patients.
Despite its efficacy on HCC, TACE presents major challenges such as the lack of quantitative biomarkers of treatment response. Dynamic contrast-enhanced MRI (DCE-MRI) enables quantitative assessment of tumor and tissue enhancement, by acquiring MR signal intensity as a function of time.
Objectives: This study is conducted: 1) to develop a monitoring system based on quantifiable measures during intra-arterial treatments from dynamic MRI, using time-activity curves analyzed using a dual-input dual-compartment model, and 2) to look at blood flow curves of the MRI before the treatment, if any, for at least one tumor, without requiring any breath hold.
Design:
- Post-treatment phase group: This will be a prospective study in HCC patients undergoing TACE (including DC beads) according to their clinical standard of care. A 4D-THRIVE sequence will be performed. Single intensities before/after gadolinium-based contrast agent enhancement will be used to create time-concentration curves, which will be fitted to a simple perfusion model that accounts for the dual blood supply of the liver through the hepatic artery and the portal vein. Perfusion parameters of arterial hepatic blood flow, portal venous hepatic blood flow, total hepatic blood flow and arterial fraction will be extracted from the model and compared between HCC and surrounding cirrhotic liver. When deemed necessary, a CBCT can be acquired before chemo-embolization in way to see that the appropriate artery is selected for the treatment. The CBCT will be used when available to determine the parameters of the blood flow obtained with our model.
- Pre-treatment phase group: This will be a prospective study in HCC patients undergoing a MRI according to their clinical standard of care. A 4D-THRIVE sequence will be performed. Single intensities before/after gadolinium-based contrast agent enhancement will be used to create time-concentration curves, which will be fitted to a simple perfusion model that accounts for the dual blood supply of the liver through the hepatic artery and the portal vein. Perfusion parameters of arterial hepatic blood flow, portal venous hepatic blood flow, total hepatic blood flow and arterial fraction will be extracted from the model and compared between HCC and surrounding cirrhotic liver.
- Comparison: A comparison between the blood flow curves between the post-treatment phase group [apnea] and the pre-treatment phase group [free-breathing] will be done.
Methods: Forty patients will be selected. For twenty-nine of them [post-treatment phase group], a 4D-THRIVE sequence will be acquired within 2 weeks prior to TACE and between 6 and 8 weeks after TACE. A 4D-FLOW MRI sequence will also be included. For the remaining eleven patients [pre-treatment phase group], only a 4D-THRIVE sequence will be acquired within 2 weeks prior to treatment, if any, including a 4D-FLOW MRI sequence.
Expected results: The results of this study will provide quantitative DCE-MRI biomarkers for identification of viable tumor and tumor response. In addition, presence of increased % arterial flow and decreased portal venous flow in HCC using DCE-MRI are expected to help to assess treatment response.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-treatment phase group | – | Device: Post-treatment phase group29 patients will undergo: 4D-THRIVE and 4D-FLOW sequences during magnetic resonance imaging (MRI) before and after transarterial chemoembolisation (TACE). |
| Pre-treatment phase group | – | Device: Pre-treatment phase group11 patients will undergo: 4D-THRIVE and 4D-FLOW sequences during magnetic resonance imaging (MRI) before treatment (if any). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is adults with a hepatocellular carcinoma (HCC). The post-treatment phase group will also encompass patients with a planned transarterial chemoembolization (TACE). For the purpose of this study, the investigators will recruit patients who will be treated at the CHUM.
Key inclusion criteria (13 listed)
- All patients:
- Post-treament phase group:
- Pre-treatment phase group:
Key exclusion criteria (4 listed)
- Have any contra-indication for MRI (such as claustrophobia, pacemaker, metallic clips for a neurosurgical procedure);
- Are pregnant or trying to become pregnant;
- Have a weight or girth preventing them from entering the MR magnet bore;
- Are unable to understand or unwilling to provide written informed consent for this study.
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 |
|---|---|---|
| Post-treatment phase group4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI) | Device | Post-treatment phase group |
| Pre-treatment phase group4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI) | Device | Pre-treatment phase group |
Primary outcome
Hepatic and tumor blood flow before and after TACE
Time frame: Within 2 weeks before TACE and 6 to 8 weeks after TACE
Measures of hepatic and tumor blood flow will help in describing HCC angiogenesis and in determining the efficiency of TACE on the tumor.
Hepatic and tumor blood flow before HCC treatment
Time frame: Within 2 weeks before HCC treatment
Measures of hepatic and tumor blood flow will help in describing HCC angiogenesis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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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. This study is not recruiting at the moment.
An Tang, MD, MSc principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 13 inclusion and 4 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: finished, as of the sponsor's last update on 6 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hepatic and tumor blood flow before and after TACE (time frame: Within 2 weeks before TACE and 6 to 8 weeks after TACE). The study lists 2 primary outcomes in all. 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 6 Aug 2021.