CT Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Other: CT perfusion examination

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Cancer Center Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HCC patients with tumor size of less than 5 cm who would receive liver resection.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training cohort; HCC patients enrolled in our study underwent a perfusion CT examination before surgery . We used CT perfusion parameters to predict the vascular pattern of tumors.	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.
Validation cohort; HCC patients who would undergo a perfusion CT examination before surgery will be enrolled in our study from January 15, 2021. We use CT perfusion parameters to predict the vascular pattern of tumors.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is the length of time from the date of randomization until death from any cause	6 months
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2013
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; CT perfusion parameters; vascular pattern
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: SCT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No