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3D-MPUS for Liver Cancer (3DMPUS Trial)
N/A
Recruiting
Led By Aya Kamaya, MD
Research Sponsored by Stanford University
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 baseline and 3 months post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial studies an inexpensive & safe method that may provide info about patient treatment response for liver tumors.
Who is the study for?
This trial is for adults over 18 with liver tumors who are starting a new treatment. They must have at least one tumor between 1cm and 14cm, be willing to follow the study rules, and able to give informed consent. It's not for those with severe allergies to contrast media used in ultrasounds or CT scans, pregnant or breastfeeding women, people with certain heart conditions, kidney issues (creatinine >1.5mg/dl), or uncontrolled high blood pressure.
What is being tested?
The trial is testing how well a new imaging technique called 3D multi-parametric ultrasound (3D-MPUS) helps in making treatment decisions for liver cancer patients. This method could provide additional functional information about the tumor during therapy that current methods don't offer.
What are the potential side effects?
There may be minimal side effects from the use of ultrasound contrast agents during the imaging process; however, individuals prone to severe reactions to such contrasts are excluded from this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diagnostic yield of the 3D-MPUS data acquisition
Secondary study objectives
Inter-reader agreement for 3D-MPUS measurements at first scan
Relationship between baseline and one-month 3D-MPUS measurements and treatment response after three-months
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 3-dimensional multi-parametric ultrasound imaging (3D-MPUS)Experimental Treatment1 Intervention
Participants will receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,084 Total Patients Enrolled
4 Trials studying Hepatocellular Carcinoma
268 Patients Enrolled for Hepatocellular Carcinoma
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,500 Total Patients Enrolled
43 Trials studying Hepatocellular Carcinoma
5,612 Patients Enrolled for Hepatocellular Carcinoma
Aya Kamaya, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
35 Total Patients Enrolled
Ahmed El Kaffas, PhDPrincipal InvestigatorStanford University
Andrej Lyshchik, MD, PhDStudy DirectorThomas Jefferson University
1 Previous Clinical Trials
612 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My creatinine level is above 1.5mg/dl, indicating kidney issues.My high blood pressure is not under control.I have a heart condition involving abnormal blood flow or high blood pressure in my lungs.I am starting treatment for liver cancer soon.I can understand and am willing to sign the consent form.I have conditions like heart valve issues, blood clotting disorders, or recent blood clots.I am older than 18 years.I have a tumor that is at least 1cm but smaller than 14cm.
Research Study Groups:
This trial has the following groups:- Group 1: 3-dimensional multi-parametric ultrasound imaging (3D-MPUS)
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.