BridgeMD
New treatment option for Liver Diseases
Official title Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal
ClinicalTrials.gov ID: NCT05470205
What this study is testing
What is SHAPE measurement (Sonazoid ultrasoud contrast agent)?
SHAPE measurement (Sonazoid ultrasoud contrast agent) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for liver diseases.
Also referred to as Sonazoid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, non-randomized trial that will be conducted at three clinical sites, Thomas Jefferson University (TJU), the Hospital of the University of Pennsylvania (HUP) and University of Bern (UB). Enrollment will be allocated into one of 4 different cohorts depending on the inclusion criteria for each cohort.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All people accepted for this trial must fulfill all the following criteria:
- Be at least 18 years of age.
- Be medically stable.
- If a female of child-bearing potential, must have a negative pregnancy test.
- Be conscious and able to comply with study procedures.
You likely can't join if
- Females who are pregnant or nursing.
- Patients with pulmonary hypertension or unstable cardiopulmonary conditions
- Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment.
- Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- Patients on life support or in a critical care unit.
- Patients with unstable occlusive disease (e.g., crescendo angina)
See the full eligibility criteria
- All people accepted for this trial must fulfill all the following criteria:
- Be at least 18 years of age.
- Be medically stable.
- If a female of child-bearing potential, must have a negative pregnancy test.
- Be conscious and able to comply with study procedures.
- Have read and signed the IRB-approved Informed Consent form for participating in the study. Also there are specific for each cohort: Cohort 1:
- Be scheduled for transjugular liver biopsy where HVPG measurements will be obtained Cohort 2:
- Have clinically significant portal hypertension undergoing routine HCC surveillance Cohort 3:
- Have a diagnosis of portal hypertension and starting treatment with non-selective β-blockers Cohort 4:
- Have clinically significant portal hypertension and be scheduled for endoscopy to screen for varices
- Females who are pregnant or nursing.
- Patients with pulmonary hypertension or unstable cardiopulmonary conditions
- Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment.
- Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- Patients on life support or in a critical care unit.
- Patients with unstable occlusive disease (e.g., crescendo angina)
- Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
- Patients with uncontrolled congestive heart failure (NYHA Class IV)
- Patients with recent cerebral hemorrhage.
- Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
- Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat...
- Patients with congenital heart defects.
- Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
- Patients with respiratory distress syndrome
- Patients with thrombosis within the hepatic, portal, or mesenteric veins.
- Patients with grade 2 and above of hepatic encephalopathy within the last 3 months Also there is one additional exclusion criteria for cohort 1:
- Patients with a history of anaphylactic allergy to perflutren (PEG) or any other components of Definity
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- Bern, Switzerland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.