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

NCT ID: NCT06705075

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Uterine Fibroid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Uterine fibroids

Group Type: EXPERIMENTAL

Perfluten

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Priscilla Machado

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Priscilla Machado, MD

Role: CONTACT

priscilla.machado@jefferson.edu

215-955-4279

Facility Contacts

Priscilla Machado

Role: primary

priscilla.machado@jefferson.edu

2159554279

Other Identifiers

iRISID-2024-0851

Identifier Type: -

Identifier Source: org_study_id