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Enhanced Ultrasound Imaging for Fatty Liver Disease
N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-ultrasound imaging and 1 day after the ultrasound imaging (within 2 weeks timeframe)
Awards & highlights
Study Summary
This trial looks at the safety and effectiveness of a medical imaging technique (SWE) that uses increased sound pressure to better image the liver. It will use blood tests to measure any possible side effects.
Who is the study for?
This trial is for adults aged 18-65 with a BMI of 18.5-39.9 who have non-alcoholic fatty liver disease and can handle repeated blood tests. They must not be pregnant, have had recent acute illnesses or liver injuries, nor plan to change their medications during the study.Check my eligibility
What is being tested?
The trial is testing an enhanced ultrasound system by GE that uses increased acoustic output to improve imaging for fatty liver disease. It checks if this new setting causes any bioeffects by monitoring liver function before and after its use.See study design
What are the potential side effects?
Potential side effects are related to changes in liver function as detected by blood tests post-imaging using the enhanced ultrasound settings. These will be monitored closely following the NCI scale for drug hepatotoxicity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-ultrasound imaging and 1 day after the ultrasound imaging (within 2 weeks timeframe)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-ultrasound imaging and 1 day after the ultrasound imaging (within 2 weeks timeframe)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean difference in alanine transaminase (ALT) value in U/L unit between pre-imaging and day7 post-imaging
Mean difference in alkaline phosphatase (ALP) value in U/L unit between pre-imaging and day7 post-imaging
Mean difference in aspartate transaminase (AST) value in U/L unit between pre-imaging and day7 post-imaging
Secondary outcome measures
Mean difference in IQR/Median ratio between standard and CIO SWE
Mean difference in alanine transaminase (ALT) value in U/L unit between pre-imaging and day1 post-imaging
Mean difference in alanine transaminase (ALT) value in U/L unit between pre-imaging and day2 post-imaging
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 24 healthy adult volunteersExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,617 Total Patients Enrolled
14 Trials studying Non-alcoholic Fatty Liver Disease
823 Patients Enrolled for Non-alcoholic Fatty Liver Disease
GE HealthcareIndustry Sponsor
291 Previous Clinical Trials
631,072 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
152 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.My medications and supplements have not changed in the last 30 days.I plan to change my current medication or supplement regimen during the study.I have been sick with an acute illness in the last 30 days.I have received a liver transplant in the past.I have not had chemotherapy in the last 30 days.I can have multiple blood tests done.I can have an abdominal ultrasound.I have liver damage caused by medication.I drink less than 7 units of alcohol per week if female, or less than 14 if male.
Research Study Groups:
This trial has the following groups:- Group 1: 24 healthy adult volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial extend to individuals aged eighty or higher?
"This clinical trial stipulates that participants must be 18 years or older and not exceed 65 years of age, as per the specified inclusion criteria."
Answered by AI
Do I qualify for participation in this experiment?
"Acceptance into the trial necessitates a diagnosis of non-alcoholic fatty liver disease and an age between 18 and 65. The medical team is looking to evaluate 24 participants in total."
Answered by AI
Are new applicants being accepted into this clinical research study?
"Clinicaltrials.gov confirms that this medical trial, initially posted on April 30th 2023, is not presently recruiting patients. However, 241 other trials are actively seeking volunteers at the present moment."
Answered by AI
What are the primary objectives of this trial?
"According to the research sponsor, GE Healthcare, this clinical trial's main objective is measuring Mean Difference of alanine transaminase (ALT) value in U/L unit between pre-ultrasound imaging and post-imaging 7 days later. Secondary outcomes include assessing AST values for potential liver injury effect at day 1 and day 2, as well as ALP values at day 1."
Answered by AI
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