Evaluation of Uterine Fibroids by CEUS and SHAPE Pre and Post UAE
ConditionUterine Fibroid
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThomas Jefferson University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 on life support or in a critical care unit.
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
Trial design
Design model
Single group
Treatments tested in this trial
Perfluten
DrugUse 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).
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Uterine fibroidsExperimental treatment 1 intervention
Trial outcomes
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).
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.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov