NCT06705075 Evaluation of Uterine Fibroids by CEUS and SHAPE Pre and Post UAE
| NCT ID | NCT06705075 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Thomas Jefferson University |
| Condition | Uterine Fibroid |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-01-27 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study goals are to determine the patterns of uterine fibroid vascularity pre and post UAE using CEUS resulting in an alternative to gadolinium-enhanced MRI that is less expensive, has less contra-indications and side effects, is real time, and noninvasive helping physicians to evaluate the result of UAE procedures. Also, this study will evaluate uterine fibroid pressures using SHAPE, comparing the results with normal myometrium tissue in order to determine its characteristics and tissue differences, which we believe will lead to the development of a new biomarker for the diagnosis and treatment of uterine fibroids.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06705075 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Uterine Fibroid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06705075 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06705075 currently recruiting?
Yes, NCT06705075 is actively recruiting participants. Contact the research team at priscilla.machado@jefferson.edu for enrollment information.
Where is the NCT06705075 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06705075 clinical trial?
NCT06705075 is sponsored by Thomas Jefferson University. The trial plans to enroll 80 participants.