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Evaluating Uterine Fibroids with CEUS and SHAPE After UAE

This study is looking at women with uterine fibroids who are scheduled for a uterine artery embolization (UAE) procedure. Researchers will use a contrast-enhanced ultrasound (CEUS) with a drug called Perfluten (UCA Definity) and a new technique called subharmonic-aided pressure estimation (SHAPE) to examine your fibroids before and after your UAE. The goal is to see if these methods can effectively evaluate fibroids, potentially offering a safer and less expensive alternative to MRI. They also hope to learn more about fibroid tissue characteristics to develop new ways to diagnose and treat them. The study aims to enroll 80 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 80 women. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your fibroids will be evaluated for up to 2 years after your UAE procedure.

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NCT06705075

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

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Thomas Jefferson University
~80 participants
Updated 2025-04-10 on ClinicalTrials.gov
What's tested:Perfluten

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE).
Measured over 2 years

Conditions

Uterine Fibroid

Explore related trials

Endometrial CarcinomaUterine Corpus Leiomyoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Priscilla Machado, MD
[email protected]
215-955-4279
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE).2 years

    This is an open-label, non-randomized, single center, clinical study that will be conducted at TJU. This trial of CEUS and SHAPE imaging examinations will evaluate the microvascularity of uterine fibroids in order to determine vascularity characteristics before,2 weeks, as well as 3 months after UAE to assess the success of the UAE procedure in short term follow-up.