CT Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Computed Tomography Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04715321
• Other study ID #: SCT-01
• Status: Recruiting
• Start date: February 15, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• CT perfusion examination
CT perfusion was performed with a 64-section multidetector CT scanner. The following CT parameters were used to acquire dynamic data: blood flow (BF), blood volume (BV), mean transit time (MTT), permeability-surface area product (PS), hepatic artery ejection fraction (HAF), hepatic artery perfusion (HAP), and hepatic portal vein perfusion (PVP). And we used these parameters to predict the vascular pattern.

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive performance of CT perfusion	The primary outcome of our study is to evaluate the sensitivity and specifity of CT perfusion in predicting vascular pattern of HCC	6 months
Secondary	Overall survival (OS)	OS is the length of time from the date of randomization until death from any cause	6 months
Secondary	Disease-free survival (DFS)	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)	6 months