Perfluten for Uterine Fibroids

Overseen By Priscilla Machado, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Thomas Jefferson University

Disqualifiers: Pregnancy, Nursing, Medically unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

80 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken an investigational drug in the last 30 days, you may not be eligible to participate.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-UAE Evaluation

Evaluation of uterine fibroid vascularity and pressures using CEUS and SHAPE before UAE

1-2 weeks

1 visit (in-person)

Post-UAE Evaluation

Evaluation of uterine fibroid vascularity and pressures using CEUS and SHAPE 2 weeks and 3 months after UAE

3 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

Treatment Details

Interventions

• Perfluten

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+