Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging
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|ClinicalTrials.gov Identifier: NCT02786199|
Recruitment Status : Unknown
Verified May 2016 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : May 30, 2016
Last Update Posted : May 30, 2016
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.
|Condition or disease|
|Neoplastic Disease Pathology|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
patients HCC who are going to receive surgical resection
- Recurrence-free survival [ Time Frame: within two years after surgery ]Suspected recurrences will be confirmed by CT or MRI.
- Liver-related mortality [ Time Frame: five years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786199
|Contact: Ming-Chih Ho, MD||+886223123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 10051|
|Contact: Ming-Chih Ho, MD/PhD 886-2-2312-3456 ext 65916 email@example.com|
|Principal Investigator: Ming-Chih Ho, MD/PhD|
|Principal Investigator:||Ming-Chih Ho, MD||Department of Surgery, National Taiwan University Hospital|