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

NCT06705075 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: iRISID-2024-0851
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Uterine fibroids

EXPERIMENTAL

Drug: Perfluten

Interventions

Perfluten 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).

Uterine fibroids

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Priscilla Machado, MD

CONTACT

215-955-4279; priscilla.machado@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 26, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 10, 2025

Record last verified: 2024-11

Locations

US (1)