Evaluating uterine fibroids using ultrasound techniques before and after treatment
Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE)
This study is testing if a special ultrasound can help women with uterine fibroids see how their condition changes before and after a specific treatment called uterine artery embolization.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06705075 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the vascular patterns of uterine fibroids before and after uterine artery embolization (UAE) using contrast-enhanced ultrasound (CEUS). The goal is to provide a cost-effective, non-invasive alternative to gadolinium-enhanced MRI, which has more contraindications and side effects. Additionally, the study will analyze uterine fibroid pressures using SHAPE technology to identify differences between fibroid and normal myometrium tissue, potentially leading to new biomarkers for diagnosis and treatment. The study involves female participants diagnosed with endometrial cancer who are scheduled for UAE.
Who should consider this trial
Good fit: Ideal candidates are females over 18 years old diagnosed with endometrial cancer and scheduled for UAE.
Not a fit: Patients who are pregnant, nursing, or have serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more accessible method for evaluating uterine fibroids and their treatment outcomes.
How similar studies have performed: While this approach is innovative, it remains to be seen if similar studies have demonstrated success with these specific methodologies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Priscilla Machado, MD
- Email: priscilla.machado@jefferson.edu
- Phone: 215-955-4279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.