Stiffness Measurement of Liver Tumors and Visceral Parenchyma

NCT ID: NCT01343212

Last Updated: 2011-05-18

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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The investigators are measuring hepatocellular carcinoma(HCC)stiffness using Acoustic Radiation Force Impulse (ARFI) technique to enhance the diagnostic accuracy for HCC stratifications and treatment efficacy.

Detailed Description

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Regression modelings as well as validity testings including cut-off identification will be acquired by performing both qualitative and quantitative measurements of HCC using reference diagnostic modalities e.g. pathology grading, dynamic CT scanning, etc.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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newly diagnosed HCC

* Subjects with newly diagnosed untreated hepatocellular carcinoma (HCC) will be enrolled.
* Subjects with the following conditions will be excluded:

liver cancer other than HCC, treated HCC, post major abdominal surgery, contraindications to liver tumor biopsy, contraindications to local percutaneous treatment of liver tumors, low quality ARFI measurement

stiffness measurement using ARFI

Intervention Type OTHER

Stiffness measurement will be performed for HCC using ARFI technique.

Interventions

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stiffness measurement using ARFI

Stiffness measurement will be performed for HCC using ARFI technique.

Intervention Type OTHER

Other Intervention Names

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Acuson S2000

Eligibility Criteria

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Inclusion Criteria

with HCC

Exclusion Criteria

* subjects with liver cancer other than HCC
* subjects with treated HCC
* post major abdominal surgery
* contraindications to liver tumor biopsy
* contraindications to local percutaneous treatment of liver tumors
* ARFI measurement low quality
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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China Medical University Hospital

Principal Investigators

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Sheng-Hung Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

Cheng-Yuan Peng, MD,PhD

Role: STUDY_DIRECTOR

Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

Locations

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Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Hung Chen, MD

Role: CONTACT

886422052121 ext. 2264

Facility Contacts

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Sheng-Hung Chen, MD

Role: primary

886-4-22052121 ext. 2264

Other Identifiers

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DMR100-IRB-055

Identifier Type: -

Identifier Source: org_study_id

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