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
Qualifiers
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
Treatments tested in this trial
- Perfluten
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov