Hepatocellular Carcinoma Stage IIINCT05125094
Prognostic Performance of Preoperative and Follow by Gadoxetic Enhanced MRI in HCC Patients After TACE
An observational study of Hepatocellular Carcinoma Stage III, run by Shanghai Zhongshan Hospital.
Trial summary
Interventional therapy is an effective alternative for patients with hepatocellular carcinoma (HCC) who are not indicated for surgery. CT or MRI imaging findings are important diagnostic and evaluation criteria for preoperative diagnosis and postoperative efficacy evaluation of TACE. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Stage III
- What is being tested?
- TACE,Ablation
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 30 Dec 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are initially diagnosed as HCC will plans to receive first curative TACE combined with ablation and can be followed up in the hospital with contrast enhanced MRI
Who may be able to join
- Patients who will be initially diagnosed as HCC and plan to receive TACE, or combined with ablation as first-line treatment Age from 18 - 75 Sign ICF （Informed consent form） mainly stage B patients with Child-Pugh class A or B liver function and an ECOG score of 0-2; multiple nodular tumors; a main portal vein that is not completely blocked or is completely blocked but the compensatory collateral blood vessels have formed between the hepatic artery and portal vein
Who cannot join
- Women who are pregnant, lactating Contraindications to MRI Contrast media: Hypersensitivity General contraindications to MRI such as pacemaker, severe claustrophobia etc. Patients who received or plan to take other treatment (resection, chemical, immunotherapy drugs that will systemic effect survival) before TACE combined with ablation
- Patients with Contraindications of TACE or ablation :
- Severe liver dysfunction (Child-Pugh class C), including jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome;
- severe coagulation dysfunction that cannot be corrected;
- completely embolized main portal vein with few collateral blood vessels formed;
- wide distant metastasis with an estimated survival of < 3 months;
- significant reductions in peripheral blood leukocytes and platelets, white blood cell (WBC) count < 3.0 × 109/L (when due to hypersplenism but not toxicity of chemotherapy; therefore, it is not an absolute contraindication for TACE), and platelets < 50 × 109/L;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prognostic Performance of Preoperative and Follow up by Gadoxetic Acid-Enhanced MRI in Patients With HCC After TACE Combined With Ablation: Compared With Non-gadoxetic Enhanced MRI
Interventional therapy is an effective alternative for patients with hepatocellular carcinoma (HCC) who are not indicated for surgery. CT or MRI imaging findings are important diagnostic and evaluation criteria for preoperative diagnosis and postoperative efficacy evaluation of TACE. In addition, the recurrence rate of liver cancer is very high, even with radical treatment, the 5-year recurrence rate is still as high as 70%. Therefore, postoperative follow-up and early detection of recurrent lesions by imaging are beneficial to the prognosis and survival benefit. Gadoxetic acid is a liver-specific MRI contrast agent for the diagnosis of liver cancer, especially in early stage, or small liver cancer (<2cm). Therefore, gadoxetic acid enhanced MRI is very important for the decision making and prognosis of HCC patients. TACE combined with ablative therapy has received clinical attention, which can significantly improve the clinical efficacy and reduce liver function damage. The study forces on evaluating the changes in survival in patients with liver cancer who were scheduled to receive TACE combined with ablation and regularly followed up, compared with enhanced CT or conventional MRI as imaging assessment (preoperative diagnosis and postoperative follow-up).
Read the detailed description
China is a country with a high incidence of hepatocellular carcinoma (HCC), and the number of new cases of HCC every year accounts for more than 50% of the world, while the diagnosis rate of very early and early HCC patients in China only accounts for about 25%, and most patients cannot be operated on. Interventional therapy is an effective alternative for patients with hepatocellular carcinoma (HCC) who are not indicated for surgery. CT or MRI imaging findings are important diagnostic and evaluation criteria for preoperative diagnosis and postoperative efficacy evaluation of TACE. In addition, the recurrence rate of liver cancer is very high, even with radical treatment, the 5-year recurrence rate is still as high as 70%. Therefore, postoperative follow-up and early detection of recurrent lesions by imaging are beneficial to the prognosis and survival benefit. Currently, the main clinical follow-up methods are enhanced CT and non-gadoxetic acid enhanced magnetic resonance examination. Gadoxetic acid is a liver-specific MRI contrast agent for the diagnosis of liver cancer, especially in early stage, or small liver cancer (<2cm). Compared with enhanced CT alone, the combination of Gadoxetic acid MRI for pre-treatment diagnosis of early-stage HCC significantly improved 4-year survival. Therefore, gadoxetic acid enhanced MRI is very important for the decision making and prognosis of HCC patients. TACE combined with ablative therapy has received clinical attention, which can significantly improve the clinical efficacy and reduce liver function damage. Currently, there are few studies on the survival rate of liver cancer patients receiving TACE combined with ablative therapy with gadoxetic acid enhanced MRI. The study forces on evaluating the changes in survival in patients with liver cancer who were scheduled to receive TACE combined with ablation and regularly followed up, compared with enhanced CT or conventional MRI as imaging assessment (preoperative diagnosis and postoperative follow-up).
- Conditions
- Hepatocellular Carcinoma Stage III
- Being tested
- TACE,Ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE,AblationDevice
Transcatheter arterial chemoembolization
| Study group | Role | What they receive |
|---|---|---|
| Non-Gadoxetic MRI for diagnosis | the patients with HCC follow up with Non-Gadoxetic MRI for diagnosis Receives: Device: TACE,Ablation | |
| Gadoxetic MRI for diagnosis | the patients with HCC follow up with Gadoxetic MRI for diagnosis Receives: Device: TACE,Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Comparison of Overall Survival after TACE combined with ablation between the Two Groups
Measured: mean follow up 34 months
Secondary outcomes (1)
tumor response
Comparison of tumor response after TACE combined with ablation between the Two Groups
Measured: mean follow up 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma Stage IIIStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mengsu Zeng, PhD, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125094
- Sponsor's protocol ID
- B2020-060R
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of this study may be published in medical journals, but we will keep patient information confidential as required by law, and patient personal information will not be disclosed unless required by relevant law.
Publications
Guo J, Seo Y, Ren S, Hong S, Lee D, Kim S, Jiang Y. Diagnostic performance of contrast-enhanced multidetector computed tomography and gadoxetic acid disodium-enhanced magnetic resonance imaging in detecting hepatocellular carcinoma: direct comparison and a meta-analysis. Abdom Radiol (NY). 2016 Oct;41(10):1960-72. doi: 10.1007/s00261-016-0807-7.
PubMed 27318936Lan H, Lin G, Zhong W. A meta-analysis of the added value of diffusion weighted imaging in combination with contrast-enhanced magnetic resonance imaging for the diagnosis of small hepatocellular carcinoma lesser or equal to 2 cm. Oncol Lett. 2020 Sep;20(3):2739-2748. doi: 10.3892/ol.2020.11805. Epub 2020 Jul 3.
PubMed 32782590
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Performance of Preoperative and Follow up by Gadoxetic Acid-Enhanced MRI in Patients With HCC After TACE Combined With Ablation: Compared With Non-gadoxetic Enhanced MRI
- ClinicalTrials.gov ID
- NCT05125094
- Acronym / sponsor ID
- B2020-060R
- Conditions
- Hepatocellular Carcinoma Stage III
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Nov 2021 (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.
Interventional therapy is an effective alternative for patients with hepatocellular carcinoma (HCC) who are not indicated for surgery. CT or MRI imaging findings are important diagnostic and evaluation criteria for preoperative diagnosis and postoperative efficacy evaluation of TACE. In addition, the recurrence rate of liver cancer is very high, even with radical treatment, the 5-year recurrence rate is still as high as 70%. Therefore, postoperative follow-up and early detection of recurrent lesions by imaging are beneficial to the prognosis and survival benefit. Gadoxetic acid is a liver-specific MRI contrast agent for the diagnosis of liver cancer, especially in early stage, or small liver cancer (<2cm). Therefore, gadoxetic acid enhanced MRI is very important for the decision making and prognosis of HCC patients. TACE combined with ablative therapy has received clinical attention, which can significantly improve the clinical efficacy and reduce liver function damage. The study forces on evaluating the changes in survival in patients with liver cancer who were scheduled to receive TACE combined with ablation and regularly followed up, compared with enhanced CT or conventional MRI as imaging assessment (preoperative diagnosis and postoperative follow-up).
Detailed description
China is a country with a high incidence of hepatocellular carcinoma (HCC), and the number of new cases of HCC every year accounts for more than 50% of the world, while the diagnosis rate of very early and early HCC patients in China only accounts for about 25%, and most patients cannot be operated on. Interventional therapy is an effective alternative for patients with hepatocellular carcinoma (HCC) who are not indicated for surgery. CT or MRI imaging findings are important diagnostic and evaluation criteria for preoperative diagnosis and postoperative efficacy evaluation of TACE. In addition, the recurrence rate of liver cancer is very high, even with radical treatment, the 5-year recurrence rate is still as high as 70%. Therefore, postoperative follow-up and early detection of recurrent lesions by imaging are beneficial to the prognosis and survival benefit. Currently, the main clinical follow-up methods are enhanced CT and non-gadoxetic acid enhanced magnetic resonance examination. Gadoxetic acid is a liver-specific MRI contrast agent for the diagnosis of liver cancer, especially in early stage, or small liver cancer (<2cm). Compared with enhanced CT alone, the combination of Gadoxetic acid MRI for pre-treatment diagnosis of early-stage HCC significantly improved 4-year survival. Therefore, gadoxetic acid enhanced MRI is very important for the decision making and prognosis of HCC patients. TACE combined with ablative therapy has received clinical attention, which can significantly improve the clinical efficacy and reduce liver function damage. Currently, there are few studies on the survival rate of liver cancer patients receiving TACE combined with ablative therapy with gadoxetic acid enhanced MRI. The study forces on evaluating the changes in survival in patients with liver cancer who were scheduled to receive TACE combined with ablation and regularly followed up, compared with enhanced CT or conventional MRI as imaging assessment (preoperative diagnosis and postoperative follow-up).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Gadoxetic MRI for diagnosis | – | Device: TACE,Ablationthe patients with HCC follow up with Non-Gadoxetic MRI for diagnosis |
| Gadoxetic MRI for diagnosis | – | Device: TACE,Ablationthe patients with HCC follow up with Gadoxetic MRI for diagnosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are initially diagnosed as HCC will plans to receive first curative TACE combined with ablation and can be followed up in the hospital with contrast enhanced MRI
Key inclusion criteria (1 listed)
- Patients who will be initially diagnosed as HCC and plan to receive TACE, or combined with ablation as first-line treatment Age from 18 - 75 Sign ICF （Informed consent form） mainly stage B patients with Child-Pugh class A or B liver function and an ECOG score of 0-2; multiple nodular tumors; a main portal vein that is not completely blocked or is completely blocked but the compensatory collateral blood vessels have formed between the hepatic artery and portal vein
Key exclusion criteria (7 listed)
- Women who are pregnant, lactating Contraindications to MRI Contrast media: Hypersensitivity General contraindications to MRI such as pacemaker, severe claustrophobia etc. Patients who received or plan to take other treatment (resection, chemical, immunotherapy drugs that will systemic effect survival) before TACE combined with ablation
- Severe liver dysfunction (Child-Pugh class C), including jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome;
- severe coagulation dysfunction that cannot be corrected;
- completely embolized main portal vein with few collateral blood vessels formed;
- wide distant metastasis with an estimated survival of < 3 months;
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 |
|---|---|---|
| TACE,AblationTranscatheter arterial chemoembolization | Device | Gadoxetic MRI for diagnosis, Non-Gadoxetic MRI for diagnosis |
Primary outcome
Overall Survival
Time frame: mean follow up 34 months
Comparison of Overall Survival after TACE combined with ablation between the Two Groups
1 secondary outcome
tumor response
Time frame: mean follow up 34 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Results publication: PubMed 27318936Guo J, Seo Y, Ren S, Hong S, Lee D, Kim S, Jiang Y. Diagnostic performance of contrast-enhanced multidetector computed tomography and gadoxetic acid disodium-enhanced magnetic resonance imaging in detecting hepatocellular carcinoma: direct comparison and a meta-analysis. Abdom Radiol (NY). 2016 Oct;41(10):1960-72. doi: 10.1007/s00261-016-0807-7.
- Results publication: PubMed 32782590Lan H, Lin G, Zhong W. A meta-analysis of the added value of diffusion weighted imaging in combination with contrast-enhanced magnetic resonance imaging for the diagnosis of small hepatocellular carcinoma lesser or equal to 2 cm. Oncol Lett. 2020 Sep;20(3):2739-2748. doi: 10.3892/ol.2020.11805. Epub 2020 Jul 3.
- Individual participant dataSharing planned: No. The results of this study may be published in medical journals, but we will keep patient information confidential as required by law, and patient personal information will not be disclosed unless required by relevant law.
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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.
Mengsu Zeng, PhD study director
Shanghai Zhongshan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Stage III, run by Shanghai Zhongshan Hospital.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Ding, PhD (+86-02164041990, ding.ying@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: mean follow up 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05125094, which also lists 2 linked publications.
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 18 Nov 2021.