Evaluation of Uterine Fibroids by CEUS and SHAPE Pre and Post UAE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perfluten.
- Who it may be relevant to
- Registry conditions: Uterine Fibroid. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE)
Overview
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.
Interventions
- Drug 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 measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Thomas Jefferson University — Philadelphia
Identifiers
NCT: NCT06705075 · iRISID-2024-0851