Hepatocellular CarcinomaNCT01343212
Stiffness Measurement of Liver Tumors and Visceral Parenchyma
An observational study of Hepatocellular Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- stiffness measurement using ARFI
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subjects with hepatocellular carcinoma(HCC)
Who may be able to join
- with HCC
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
Taichung, 40447
Sheng-Hung Chen, MD, 886-4-22052121 ext. 2264, shcvghtc@gmail.com
Sheng-Hung Chen, MD
About this study
Official title: Clinical Applications of Acoustic Radiation Force Impulse Technology in Stiffness Measurement of Liver Tumors and Visceral Parenchyma
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- stiffness measurement using ARFI
- Keywords
- hepatocellular carcinoma, stiffness
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stiffness measurement using ARFIOther
Also called Acuson S2000
Stiffness measurement will be performed for HCC using ARFI technique.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: stiffness measurement using ARFI |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sheng-Hung Chen, MD, Principal investigator, Hepatogastroenterology, Department of Internal Medicine, China Medical University HospitalCheng-Yuan Peng, MD,PhD, Study director, Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343212
- Sponsor's protocol ID
- DMR100-IRB-055
- Status last verified
- May 2011
- First submitted
- 26 Apr 2011
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications of Acoustic Radiation Force Impulse Technology in Stiffness Measurement of Liver Tumors and Visceral Parenchyma
- ClinicalTrials.gov ID
- NCT01343212
- Acronym / sponsor ID
- DMR100-IRB-055
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newly diagnosed HCC | – | Other: stiffness measurement using ARFI* 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with hepatocellular carcinoma(HCC)
Key inclusion criteria (1 listed)
- with HCC
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stiffness measurement using ARFIAlso: Acuson S2000Stiffness measurement will be performed for HCC using ARFI technique. | Other | newly diagnosed HCC |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng-Hung Chen, MD principal investigator
Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
Cheng-Yuan Peng, MD,PhD study director
Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Hung Chen, MD (886422052121 ext. 2264, shcvghtc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.