Visceral StiffnessARFINCT01311934
Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse
An observational study of Visceral Stiffness and Liver Fibrosis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The acoustic radiation force impulse (ARFI) technology provides real-time measurements of tissue stiffness. Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis scoring and to conduct… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Stiffness, Liver Fibrosis
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Feb 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: Patients with chronic liver diseases
Who may be able to join
- patients with chronic liver diseases who underwent liver biopsy
- patients with pathologically or radiologically proven cirrhosis
Who cannot join
- Post major abdominal surgery
- After interferon or neucleos(t)ides treatment
- PBC,PSC,WD,AIH,viral coinfections
- Liver abscess
- Exposure to hepatotoxic drugs or chemicals
- Thrombosis of splenic vein, portal veins
Show all 15Show fewer
- After resection or embolism of the spleen
- Acute or chronic pancreatitis
- Biopsy contraindications (not exclusive)
- ARFI measurements low quality
- Fibrotest contraindications:
- Acute hepatitides, Extrahepatic cholestasis, e.g., pancreatic cancer, gallstones, CBD>0.7cm Severe hemolysis
- Cardiac congestion
- Liver cancer other than HCC
- Treated HCC
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 40447
Sheng-Hung Chen, MD, 886422052121 ext. 2264, shcvghtc@gmail.com
About this study
Official title: Clinical Application of the Spectrum of Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse Technology
The acoustic radiation force impulse (ARFI) technology provides real-time measurements of tissue stiffness.
Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis scoring and to conduct subsequent innovative studies on liver diseases.
Read the detailed description
Using ARFI technology, we are establishing a complete hepatic and visceral shear wave spectrum to correspond to the entire METAVIR fibrosis scoring and various functional stratifications.
- Conditions
- Visceral Stiffness, Liver Fibrosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HBV-infected | Not described | |
| HCV-infected | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral StiffnessStudies of the same condition, open and under way.
- 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
- 200 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
- NCT01311934
- Sponsor's protocol ID
- DMR100-IRB-001
- Acronym
- ARFI
- Status last verified
- May 2011
- First submitted
- 7 Mar 2011
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of the Spectrum of Visceral Stiffness Measurement Using Acoustic Radiation Force Impulse Technology
- ClinicalTrials.gov ID
- NCT01311934
- Acronym / sponsor ID
- ARFI / DMR100-IRB-001
- Conditions
- Visceral Stiffness, Liver Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 10 Mar 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 acoustic radiation force impulse (ARFI) technology provides real-time measurements of tissue stiffness.
Aim: Using the ARFI ultrasonography, the investigators aims are to complete the correlation and validity studies between visceral ARFI quantification and the referenced Metavir fibrosis scoring and to conduct subsequent innovative studies on liver diseases.
Detailed description
Using ARFI technology, we are establishing a complete hepatic and visceral shear wave spectrum to correspond to the entire METAVIR fibrosis scoring and various functional stratifications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBV-infected | – | – |
| HCV-infected | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver diseases
Key inclusion criteria (2 listed)
- patients with chronic liver diseases who underwent liver biopsy
- patients with pathologically or radiologically proven cirrhosis
Key exclusion criteria (15 listed)
- Post major abdominal surgery
- After interferon or neucleos(t)ides treatment
- PBC,PSC,WD,AIH,viral coinfections
- Liver abscess
- Exposure to hepatotoxic drugs or chemicals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 26 May 2011.
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 Visceral Stiffness and Liver Fibrosis, 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 2 inclusion and 15 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 26 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 26 May 2011.