Prognostic Performance of Preoperative and Follow by Gadoxetic Enhanced MRI in HCC Patients After TACE

NCT ID: NCT05125094

Last Updated: 2021-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-12-30

Brief 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. 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).

Conditions

Hepatocellular Carcinoma Stage III

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-Gadoxetic MRI for diagnosis

the patients with HCC follow up with Non-Gadoxetic MRI for diagnosis

TACE,Ablation

Intervention Type: DEVICE

Transcatheter arterial chemoembolization

Gadoxetic MRI for diagnosis

the patients with HCC follow up with Gadoxetic MRI for diagnosis

TACE,Ablation

Intervention Type: DEVICE

Transcatheter arterial chemoembolization

Interventions

TACE,Ablation

Transcatheter arterial chemoembolization

Intervention Type: DEVICE

Eligibility Criteria

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 :

1. Severe liver dysfunction (Child-Pugh class C), including jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome;

2. severe coagulation dysfunction that cannot be corrected;

3. completely embolized main portal vein with few collateral blood vessels formed;

4. wide distant metastasis with an estimated survival of < 3 months;

5. 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mengsu Zeng, PhD

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital

Central Contacts

Ying Ding, PhD

Role: CONTACT

Phone: +86-02164041990

Email: ding.ying@zs-hospital.sh.cn

References

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.

Reference Type: RESULT

PMID: 27318936 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32782590 (View on PubMed)

Other Identifiers

B2020-060R

Identifier Type: -

Identifier Source: org_study_id