Recruiting
Phase 2

CEUS & SHAPE

Sponsor:

Thomas Jefferson University

Code:

NCT06705075

Conditions

Uterine Fibroid

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Perfluten

Study Details

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 ID

NCT06705075

Start date

Jan 27, 2025

Status verified date

Nov, 2024

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Uterine fibroids

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Priscilla Machado, MD

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

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Priscilla Machado

2159554279priscilla.machado@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 10, 2025

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-04-10.