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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Fibroid
• Intervention / Treatment: Drug: Perfluten

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Priscilla Machado, MD; Phone Number: 215-955-4279; Email: priscilla.machado@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
      • Contact: Priscilla Machado; Phone Number: 2159554279; Email: priscilla.machado@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Uterine fibroids	Drug: Perfluten; Use of UCA Definity to evaluate uterine fibroids by contrast-enhanced ultrasound (CEUS) and subharmonic-aided pressure estimation (SHAPE) pre and post-uterine artery embolization (UAE).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: iRISID-2024-0851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No