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Stiffness Measurement of Liver Tumors and Visceral Parenchyma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01343212
First received: April 26, 2011
Last updated: May 17, 2011
Last verified: May 2011
History of Changes
  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:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sheng-Hung Chen, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01343212     History of Changes
Other Study ID Numbers: DMR100-IRB-055
Study First Received: April 26, 2011
Last Updated: May 17, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
hepatocellular carcinoma
stiffness

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

ClinicalTrials.gov processed this record on June 17, 2013