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

NCT05125094 | Unknown

• 1 other identifier: B2020-060R
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hepatocellular Carcinoma Stage III

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Comparison of Overall Survival after TACE combined with ablation between the Two Groups

  mean follow up 34 months

Secondary Outcomes (1)

• tumor response

  mean follow up 34 months

Study Arms (2)

Non-Gadoxetic MRI for diagnosis

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

Device: TACE,Ablation

Gadoxetic MRI for diagnosis

the patients with HCC follow up with Gadoxetic MRI for diagnosis

Device: TACE,Ablation

Interventions

TACE,Ablation DEVICE

Transcatheter arterial chemoembolization

Gadoxetic MRI for diagnosis; Non-Gadoxetic MRI for diagnosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (2)

• 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.

  PMID: 27318936 RESULT

• 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.

  PMID: 32782590 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Mengsu Zeng, PhD

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Ying Ding, PhD

CONTACT

+86-02164041990; ding.ying@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 18, 2021
• Study Start: December 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: December 30, 2025
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share