NCT01343212

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 18, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

April 26, 2011

Last Update Submit

May 17, 2011

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomastiffness

Study Arms (1)

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

Interventions

stiffness measurement using ARFIOTHER

Stiffness measurement will be performed for HCC using ARFI technique.

Also known as: Acuson S2000
newly diagnosed HCC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects with hepatocellular carcinoma(HCC)

You may qualify if:

  • with HCC

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Sheng-Hung Chen, MD

    Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

    PRINCIPAL INVESTIGATOR

  • Cheng-Yuan Peng, MD,PhD

    Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital

    STUDY DIRECTOR

Central Study Contacts

Sheng-Hung Chen, MD

CONTACT

886422052121shcvghtc@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 28, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 18, 2011

Record last verified: 2011-05

Locations

TW(1)