Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging

NCT02786199 | Unknown

• 1 other identifier: 201505107RINA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplastic Disease; Pathology

Keywords

Hepatocellular Carcinoma(HCC); Ultrasound; Backscatter; Differentiation grade; Survival

Outcome Measures

Primary Outcomes (2)

• Recurrence-free survival

  Suspected recurrences will be confirmed by CT or MRI.

  within two years after surgery

• Liver-related mortality

  five years

Study Arms (1)

Hepatocellular carcinoma

patients HCC who are going to receive surgical resection

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HCC who have received surgical resection

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ming-Chih Ho, MD

  Department of Surgery, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Chih Ho, MD

CONTACT

+886223123456; mcho1215@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: May 30, 2016
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 30, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)