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

Last updated: April 7, 2025
Sponsor: Thomas Jefferson University
Overall Status: Active - Recruiting

Phase

2

Condition

Sarcoma (Pediatric)

Desmoid Tumors

Uterina Myoma

Treatment

Perfluten

Clinical Study ID

NCT06705075
iRISID-2024-0851
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Females who are pregnant or nursing.

  • Patients who have received an investigational drug in the 30 days before study drugadministration, 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 ventriculartachycardia.

  • Patients with recent cerebral hemorrhage.

  • Patients who have undergone surgery within 24 hours prior to the study sonographicexamination.

  • Patients with congenital heart defects.

  • Patient with a known allergy to Definity.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Perfluten
Phase: 2
Study Start date:
January 27, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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