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

Thomas Jefferson University

Status and phase

Enrolling

Phase 2

Conditions

Uterine Fibroid

Treatments

Drug: Perfluten

Study type

Interventional

Funder types

Other

Identifiers

NCT06705075

iRISID-2024-0851

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.