CT Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT04715321
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Distinct vascular patterns (ECTC or Non-ECTC) of tumors plays an important role in tumor migration, metastasis and drug resistant in hepatocellular carcinoma (HCC). However, there is no non-invasive method to predict vascular pattern in clinical. In the present study, we prospectively assess CT perfusion parameters for evaluation of the vascular pattern in HCC.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-15
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-20
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. age over than 18 years old
2. tumor size of less than 5 cm
3. Child-Pugh A class liver function
4. an Eastern Cooperative Oncology Group performance status of 0
5. no previous treatment for HCC
6. pathological diagnosis of hepatocellular carcinoma
7. adequate organ function (white blood cell count ≥3.0 × 109/L, absolute neutrophil count ≥1.5 × 109/L, platelet count ≥75 × 109/L, aspartate transaminase and alanine transaminase≤5 × upper limit of the normal, creatinine clearance rate of ≤1.5 × upper limit of the normal, and left ventricular ejection ≥45%)

Exclusion Criteria

1. Patients who received antitumor therapy before recurrence, including radiotherapy, transarterial chemoembolization, tyrosine kinase inhibitor, and immune checkpoint inhibitor
2. a known medical history of HIV infection
3. pregnancy or breastfeeding
4. portal vein tumor thrombosis or hepatic vein thrombosis detected by any routine imaging modality, including ultrasonography, dynamic contrast CT and MRI
5. any evidence of tumor metastasis or prior recurrence
6. hepatic decompensation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive performance of CT perfusion	6 months	The primary outcome of our study is to evaluate the sensitivity and specifity of CT perfusion in predicting vascular pattern of HCC

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	6 months	OS is the length of time from the date of randomization until death from any cause
Disease-free survival (DFS)	6 months	Disease-free survival is calculated from the date of surgery to tumor recurrence or death from any cause (or the date of the last follow-up if the patient was alive)

Trial Locations

Locations (1)

Cancer Center Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China