Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging

Histological grade of hepatocellular carcinoma (HCC) is an important prognostic factor affecting patient survival. It has been divided into four grades from I to IV on the basis of histological differentiation. Grade I is the best differentiated consisting of small tumor cells arranged in thin trabeculae. Cells with higher grade are larger and less differentiated with hyperchromatic nuclei and loss of trabecular pattern.

Ultrasound is an imaging modality frequently used to evaluate liver tumors because of its convenience, real-time, less expensive and no radiation exposure. However, ultrasonographic evaluation by conventional B-mode image is semi quantitative and subjective. It still cannot replace liver biopsy for the evaluation of HCC.

This study is aimed to quantify the image characters of B-mode image and the scatterer properties using Nakagami distribution. Nakagami parameter is a general model to describe the distribution of scatterers. Therefore, the investigators hypothesized that Nakagami parameter may also reflect the histological changes in different grades of HCC.

In this study, the resected HCC tumor samples will be collected from the participants who are going to receive surgical resection, and the tumor US images and Nakagami values will be obtained via the single-element ultrasound system. The correlation between the ultrasound backscatter parameter and the differentiation grade will be analyzed.

Study Overview

• Status: Unknown
• Conditions: Neoplastic Disease; Pathology

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10051
    • Recruiting
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with HCC who have received surgical resection

Description

Inclusion Criteria:

• Age 21 to 75
• Patients with HCC who underwent surgery
• The resected tumor was measured larger than 3 cm

Exclusion Criteria:

• Patients who have received other treatment in 6 months
• Patients who couldn't regular follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hepatocellular carcinoma; patients HCC who are going to receive surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival	Suspected recurrences will be confirmed by CT or MRI.	within two years after surgery
Liver-related mortality		five years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ming-Chih Ho, MD, Department of Surgery, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Estimate): May 30, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Ultrasound; Survival; Backscatter; Hepatocellular Carcinoma(HCC); Differentiation grade
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 201505107RINA

Plan for Individual participant data (IPD)

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