Perfluten for Uterine Fibroids

Overseen By Priscilla Machado, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Thomas Jefferson University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

This trial is for women over 18 with uterine fibroids scheduled for UAE treatment. Participants must not be pregnant and should be able to follow study procedures. They need to understand and sign a consent form approved by an ethics board.

Inclusion Criteria

I have read and signed the consent form for this study.

I am mentally alert and can follow study instructions.

I am a woman diagnosed with endometrial cancer and scheduled for uterine artery embolization.

Treatment Details

Interventions

• Perfluten (Contrast Agent)

Trial Overview The study tests the use of CEUS (Contrast-Enhanced Ultrasound) as a less invasive, real-time alternative to MRI for monitoring uterine fibroid vascularity before and after UAE. It also assesses SHAPE technology to measure fibroid pressures, potentially leading to new biomarkers.

Participant Groups

Group I: Uterine fibroids Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+