iLivTouch vs FibroScan for Liver Health

Not currently recruiting at 3 trial locations

Overseen By Calvin Q Pan, Dr

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New Discovery LLC

Disqualifiers: Excessive drinking, Decompensated cirrhosis, Tumors, Ascites, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods, iLivTouch and FibroScan, for detecting liver fibrosis (scarring) and steatosis (fat build-up) in adults. Participants will divide into two groups to receive both tests in different orders. It targets adults who need a liver check-up, have recent test results, and are willing to join the study. As an unphased trial, this study offers participants the chance to contribute to advancements in liver health diagnostics.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these devices are safe for assessing liver fibrosis and steatosis?

Research has shown that both iLivTouch and FibroScan safely assess liver health. iLivTouch effectively diagnoses liver issues without reported safety problems or known side effects, offering a comfortable option for liver checks.

FibroScan, a noninvasive tool, functions like a special ultrasound to measure liver stiffness and fat content. It causes no pain and requires no sedation, ensuring patient safety.

Both tools are gentle on the body and provide valuable information about liver health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to compare iLivTouch and FibroScan, two non-invasive tools, in assessing liver fibrosis and steatosis. Unlike traditional liver biopsies, which are invasive and carry risk, both iLivTouch and FibroScan offer a safer, quicker way to evaluate liver health. iLivTouch is particularly intriguing as it may provide a more portable and user-friendly option, potentially increasing accessibility for patients. By determining how these two methods stack up against each other, researchers hope to enhance early detection and monitoring of liver conditions in a more patient-friendly manner.

What evidence suggests that iLivTouch and FibroScan are effective for assessing liver fibrosis and steatosis?

This trial will compare the effectiveness of iLivTouch and FibroScan in assessing liver stiffness and fat changes. Research has shown that both iLivTouch and FibroScan effectively check liver stiffness and fat changes. Participants will be randomized to receive measurements using either iLivTouch first followed by FibroScan, or FibroScan first followed by iLivTouch. iLivTouch typically measures liver stiffness at 10.3, while FibroScan measures it at 7.2, indicating a close relationship. Studies have confirmed that FibroScan is a trusted method for detecting liver problems, providing reliable results on liver hardness and fat levels. Both tools are noninvasive, meaning they don't involve surgery or needles, and they provide important information about liver health. This evidence suggests that both iLivTouch and FibroScan are helpful for assessing liver fibrosis and fat buildup. ^{5 6 7 8 9}

Who Is on the Research Team?

Calvin Q. Pan

Principal Investigator

New York University Langone Health

Are You a Good Fit for This Trial?

Inclusion Criteria

You have had recent tests to measure platelet count, ALT, AST, globulin, HBA1c and total bilirubin levels.

You are willing and able to sign an Informed Consent Form (ICF) to participate in the clinical study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo liver stiffness and steatosis assessment using iLivTouch and FibroScan devices

6 months

Multiple visits for device assessments

Follow-up

Participants are monitored for adverse events and effectiveness of assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

• FibroScan
• iLivTouch

How Is the Trial Designed?

Group I: iLivTouch then FibroScan Experimental Treatment 2 Interventions

Subjects in the Group "iLivTouch then FibroScan" will be measured using iLivTouch first and then FibroScan based on the randomization result.

Group II: FibroScan then iLivTouch Experimental Treatment 2 Interventions

Subjects in the Group "FibroScan then iLivTouch" will be measured using FibroScan first and then iLivTouch based on the randomization result.

Who Is Running the Clinical Trial?

New Discovery LLC

Lead Sponsor

Trials

8

Recruited

2,800+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

Wuxi Hisky Medical Technology Co Ltd

Industry Sponsor

Trials

8

Recruited

5,200+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Baylor University

Collaborator

Trials

65

Recruited

67,600+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7696616/

Diagnostic Accuracy of FibroScan and Factors Affecting ... FibroScan provides two parameters—the liver stiffness measurement (LSM) and controlled attenuation parameter (CAP)—which are useful for ...

2. mskcc.org mskcc.org/cancer-care/patient-education/understanding-your-fibroscan-results

Understanding Your Liver Elastography (FibroScan®) ... FibroScan is a special ultrasound technology that measures liver stiffness (hardness) and fatty changes in your liver.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1542356525003325

Effectiveness of Six International Guidelines Using Fibrosis ... The most widely used and validated tests for identifying patients with advanced fibrosis with high performance in MASLD are the Fibrosis-4 (FIB- ...

4. academic.oup.com academic.oup.com/gastro/article/doi/10.1093/gastro/goae024/7644342

Noninvasive tests for liver fibrosis in 2024 - Oxford Academic FibroMeter showed effectiveness in categorising patients with MASLD into different groups by using the cut-off values of 0.499, 0.754 and 0.969 ...

5. lipidworld.biomedcentral.com lipidworld.biomedcentral.com/articles/10.1186/s12944-021-01453-5

Performance of liver stiffness measurements obtained with ... This cross-sectional study demonstrated that LSM values obtained using FibroScan achieved good diagnostic performance of liver fibrosis, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3594956/

Fibroscan (Transient Elastography) for the Measurement of ... Fibroscan is a noninvasive test, it can be performed at the point of care, there is no pain, and sedation is not required.

7. racgp.org.au racgp.org.au/afp/2013/july/fibroscan

FibroScan and transient elastography FibroScan® is principally used to estimate the degree of liver scarring present (ie. stage of liver disease). This is very useful in the assessment of patients ...

8. echosens.com echosens.com/en-us/clinical-evidences/

FibroScan®, transient elastography for liver stiffness Clinical evidence: FibroScan® is powered by LSM by VCTE™ (liver stiffness), SSM (spleen stiffness) by VCTE™ - vibration-controlled transient elastography, ...

9. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2020192437

Update to the Society of Radiologists in Ultrasound Liver ... This multidisciplinary update of the Society of Radiologists in Ultrasound consensus statement on liver elastography incorporates the large volume of new ...