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Stiffness Measurement of Liver Tumors and Visceral Parenchyma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by China Medical University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343212
First Posted: April 28, 2011
Last Update Posted: May 18, 2011
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.
Information provided by:
China Medical University Hospital
  Purpose
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.

Condition Intervention
Hepatocellular Carcinoma Other: stiffness measurement using ARFI

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Applications of Acoustic Radiation Force Impulse Technology in Stiffness Measurement of Liver Tumors and Visceral Parenchyma

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Other: stiffness measurement using ARFI
Stiffness measurement will be performed for HCC using ARFI technique.
Other Name: Acuson S2000

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subjects with hepatocellular carcinoma(HCC)
Criteria

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
  Contacts and Locations
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): NCT01343212


Contacts
Contact: Sheng-Hung Chen, MD 886422052121 ext 2264 shcvghtc@gmail.com

Locations
Taiwan
Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Sheng-Hung Chen, MD    886-4-22052121 ext 2264    shcvghtc@gmail.com   
Principal Investigator: Sheng-Hung Chen, MD         
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Sheng-Hung Chen, MD Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
Study Director: Cheng-Yuan Peng, MD,PhD Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
  More Information

Responsible Party: Sheng-Hung Chen, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01343212     History of Changes
Other Study ID Numbers: DMR100-IRB-055
First Submitted: April 26, 2011
First Posted: April 28, 2011
Last Update Posted: May 18, 2011
Last Verified: May 2011

Keywords provided by China Medical University Hospital:
hepatocellular carcinoma
stiffness

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases