- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05125094
Prognostic Performance of Preoperative and Follow by Gadoxetic Enhanced MRI in HCC Patients After TACE
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ying Ding, PhD
- Phone Number: +86-02164041990
- Email: ding.ying@zs-hospital.sh.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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;
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-Gadoxetic MRI for diagnosis
the patients with HCC follow up with Non-Gadoxetic MRI for diagnosis
|
Transcatheter arterial chemoembolization
|
Gadoxetic MRI for diagnosis
the patients with HCC follow up with Gadoxetic MRI for diagnosis
|
Transcatheter arterial chemoembolization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: mean follow up 34 months
|
Comparison of Overall Survival after TACE combined with ablation between the Two Groups
|
mean follow up 34 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tumor response
Time Frame: mean follow up 34 months
|
Comparison of tumor response after TACE combined with ablation between the Two Groups
|
mean follow up 34 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mengsu Zeng, PhD, Shanghai Zhongshan Hospital
Publications and helpful links
General 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.
- Lan 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2020-060R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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