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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	TACE,Ablation	Transcatheter arterial chemoembolization

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-07-31
• Completion: 2025-12-30
• First posted: 2021-11-18
• Last updated: 2021-11-18