CT Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma

NCT04715321 | Unknown DMC

• 1 other identifier: SCT-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; CT perfusion parameters; vascular pattern

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival (OS)

  6 months

• Disease-free survival (DFS)

  6 months

Study Arms (2)

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

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

Interventions

CT perfusion examination OTHER

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.

Training cohort; Validation cohort

Eligibility Criteria

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

Study Population

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

You may qualify if:

• age over than 18 years old
• tumor size of less than 5 cm
• Child-Pugh A class liver function
• an Eastern Cooperative Oncology Group performance status of 0
• no previous treatment for HCC
• pathological diagnosis of hepatocellular carcinoma
• 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%)

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: February 15, 2013
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)