Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging

NCT ID: NCT02786199

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplastic Disease Pathology

Keywords

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Hepatocellular Carcinoma(HCC) Ultrasound Backscatter Differentiation grade Survival

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepatocellular carcinoma

patients HCC who are going to receive surgical resection

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-Chih Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ming-Chih Ho, MD

Role: CONTACT

Phone: +886223123456

Email: [email protected]

Facility Contacts

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Ming-Chih Ho, MD/PhD

Role: primary

Other Identifiers

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201505107RINA

Identifier Type: -

Identifier Source: org_study_id