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Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease
Neoplastic Disease Pathology

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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



Primary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: within two years after surgery ]
    Suspected recurrences will be confirmed by CT or MRI.

  2. Liver-related mortality [ Time Frame: five years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HCC who have received surgical resection
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Ming-Chih Ho, MD +886223123456 ext 65916 mcho1215@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10051
Contact: Ming-Chih Ho, MD/PhD    886-2-2312-3456 ext 65916    mcho1215@ntu.edu.tw   
Principal Investigator: Ming-Chih Ho, MD/PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ming-Chih Ho, MD Department of Surgery, National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02786199    
Other Study ID Numbers: 201505107RINA
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Taiwan University Hospital:
Hepatocellular Carcinoma(HCC)
Ultrasound
Backscatter
Differentiation grade
Survival
Additional relevant MeSH terms:
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Neoplasms