Evaluation of Uterine Fibroids by CEUS and SHAPE Pre and Post UAE

Launched by THOMAS JEFFERSON UNIVERSITY · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to evaluate uterine fibroids, which are non-cancerous growths in the uterus, before and after a treatment called Uterine Artery Embolization (UAE). The researchers want to see if a method called Contrast-Enhanced Ultrasound (CEUS) can provide valuable information about the blood flow in these fibroids. CEUS is a simpler and safer alternative to a type of MRI that uses a contrast dye, which can sometimes cause issues for patients. Additionally, the study will look at the pressure of the fibroids compared to normal uterine tissue to help develop a new way to diagnose and treat these conditions.

To participate in this study, you must be a woman over 18 who has been diagnosed with endometrial cancer and is scheduled for UAE. You also need to be able to understand and follow the study's procedures, and if you're able to have children, a recent pregnancy test must be negative. Participants will undergo some tests using CEUS and will be supported throughout the process. It’s important to note that certain individuals, such as pregnant or nursing women, or those with specific medical conditions, cannot participate in this trial. If you're interested or want more information, please talk to your healthcare provider.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Be a female diagnosed with endometrial cancer and scheduled for UAE.
• • Be over the age of 18 years.
• • If the subject is 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 consent form for participating in the study.
• Exclusion Criteria:
• • Females who are pregnant or nursing.
• • Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards.
• * 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 clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
• • Patients with recent cerebral hemorrhage.
• • Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
• • Patients with congenital heart defects.
• • Patient with a known allergy to Definity.