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NCT Number: NCT06705075

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

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Key information

Conditions

Uterine Fibroid Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Priscilla Machado

CONTACT

[email protected]

2159554279

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Priscilla Machado, MD

CONTACT

[email protected]

215-955-4279

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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