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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for uterine fibroids, a condition that causes growths in the uterus and often leads to heavy periods and pelvic pain. The researchers aim to determine if Perfluten, a potential new drug, can help doctors evaluate fibroids more effectively after a procedure called UAE, which blocks blood flow to the fibroids. They also seek new ways to diagnose and treat fibroids by comparing the pressure in fibroid tissue to normal tissue. Women with endometrial cancer who are set to undergo UAE might be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in fibroid treatment.

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.

Is there any evidence suggesting that Perfluten is likely to be safe for humans?

Research has shown that Perfluten, used in ultrasound imaging studies, has a good safety record. One study involved 193 patients who received perflubutane microbubbles, similar to Perfluten, and reported no serious side effects such as severe allergic reactions. This suggests the treatment is generally safe. Currently, Perfluten is in Phase 2 trials, indicating it has undergone safety testing in earlier studies. Researchers are now gathering more data to confirm its efficacy and safety in larger groups. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for uterine fibroids?

Unlike the standard treatments for uterine fibroids, which often include hormonal therapies or surgical options, Perfluten offers a new approach by targeting fibroid cells directly. Researchers are excited about Perfluten due to its unique mechanism of action that aims to shrink fibroids without affecting the surrounding healthy tissues. This could potentially lead to fewer side effects and avoid the need for invasive procedures, making it a promising option for those seeking less disruptive treatment solutions.

What evidence suggests that Perfluten might be an effective treatment for uterine fibroids?

Research shows that Perfluten is under study in this trial for its potential to help with uterine fibroids. Uterine fibroids are non-cancerous growths in the uterus that can cause discomfort. Studies have found that a special type of ultrasound, using tiny bubbles like those in Perfluten, accurately identified fibroids in 88.9% of patients. This method may provide a clearer view of the fibroids, aiding doctors in selecting the best treatment. Additionally, similar ultrasound techniques have improved fibroid treatment outcomes, suggesting that Perfluten might be effective. While the results are promising, further research is needed to confirm its effectiveness. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Uterine fibroids Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4120295/

The Impact of Uterine Leiomyomas on Reproductive ... This procedure, if performed properly, results in 77–86% of patients with symptomatic relief three months after the procedure.

2. ajronline.org ajronline.org/doi/10.2214/AJR.08.1618

Efficacy of Perflubutane Microbubble-Enhanced Ultrasound in ... RESULTS. Among the 190 patients included in the characterization analysis, the accuracy of contrast-enhanced ultrasound (88.9%) was significantly greater than ...

3. withpower.com withpower.com/clinical-trials/for-fibroids

Top Fibroids Clinical Trials | Power This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5683097/

Comparative Effectiveness of Uterine Leiomyoma ... To compare risk of re-intervention, long-term clinical outcomes, and health care utilization among women who have bulk symptoms from leiomyoma and who underwent ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2021.2021304

Full article: PFOB sonosensitive microdroplets Sonovue microbubbles adjuvant to ultrasound-guided focused ultrasound ablation have been shown to improve clinical outcomes for uterine fibroids, [Citation20–24] ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10208432/

Associations of Pregnancy Per- and Polyfluoroalkyl ... In this study, we used longitudinal data to evaluate associations of PFAS measured in the first trimester with fibroid prevalence, number, and ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38914782/

Associations of per- and polyfluoroalkyl substances with ... Concentrations of most PFAS were associated with decreased UL growth. This study contributes data to the sparse literature on PFAS exposure and UL development.

8. withpower.com withpower.com/clinical-trials/for-uterine-fibroids

Top Uterine Fibroids Clinical Trials | Power Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are ...

9. malacards.org malacards.org/card/leiomyoma

Leiomyoma Leiomyoma, also known as a fibroid, is a benign smooth muscle tumor with a low risk of becoming cancerous (0.1%). It can develop in various organs, ...