Women Needed for U of C Fibroid Treatment Study
Researchers at the University of Chicago Medicine are testing to see if MRI-guided HIFU (high-intensity focused ultrasound) will yield quicker recoveries and fewer side effects than current treatments for the removal of uterine fibroids in women.
Uterine fibroids, benign tumors, are extremely common, occurring in 20 to 50 percent of women older than 30 years of age and grow in the muscle layers of the uterus, where they can cause cramping, pain, heavy menstrual bleeding, constipation, bloating and frequent urination.
Hysterectomy (surgical removal of the uterus) is the most common treatment, requiring anesthesia, a hospital stay and recovery at home. Many women choose less-invasive approaches to symptomatic relief, such as myomectomy (surgical removal of just the fibroids) or uterine artery embolization (which blocks blood flow to the affected tissue).
“We are encouraging African American women to take part in the study. African American women tend to have more fibroids, larger fibroids and at an earlier age than white women,” said trial director Aytekin Oto, MD, professor of radiology and surgery and director of abdominal magnetic resonance imaging at the University of Chicago Medicine.
Dr. Oto also said that the occurrence of fibroids in African American women could be due to genetic disposition but the exact cause of the tumors is still uncertain.
“That’s why disparity research is important,” Dr. Oto said. “We always try to understand the reason. Is the problem genetic or is it that African American women have less screenings than Caucasian women?’ We at this point, do not clearly know. It’s why disparity research is such a hot topic now.”’
The University of Chicago Medicine is seeking about 30 women, to take part in the study.
Volunteers must be less than 50 years of age, have fibroids that affect their quality of life, and have no intention of getting pregnant.
The HIFU procedure requires no incision or general anesthesia. Subjects are typically discharged from the hospital that day.
The medical center is one of only five sites for this study in the United States. There are four additional sites in Canada and Korea.
The procedure, known as MRI-guided HIFU, uses magnetic-resonance imaging to focus heat-generating, high-intensity ultrasound onto the fibroid growths.
The procedure requires the subject to lay face-down on a special MRI table with a flexible gel pad wrapped around her abdomen. Real-time MRI scans guide the ultrasound procedure and monitor temperatures in and around targeted tissues.
During the procedure, which last about three hours, participants have a urinary catheter inserted to drain the bladder. Participants may also have an intravenous line inserted, as needed, for pain relief or conscious sedation. Once the ultrasound is finished, subjects receive an injection of a contrast agent that enhances MRI assessment of the effects.
“Participants are not exposed to surgery or radiation and should be able to return to daily normal activities the day after undergoing this procedure,” Dr. Oto said. “We work with Gynecologist, Nathaniel Crump, assistant Professor of Obstetrics/Gynecology at University of Chicago Medicine."
Because this is a controlled clinical trial, four out of five volunteers will receive the study procedure. One out of five will go through the full protocol but will not receive HIFU, and thus not experience any study procedure-related change in her fibroids. Participants will not be told whether they were given the study procedure until the three-year study is completed.
The trial brings together two rapidly advancing technologies: high-resolution magnetic resonance imaging (MRI) and high-intensity focused ultrasound (HIFU). The MRI guides and monitors therapy. HIFU's concentrated sound waves generate heat, which can destroy fibroids in an approach designed to have little or no effect on the healthy tissues around fibroids.
Participants will be compensated.
Women interested in learning more about this clinical research study should contact Ambereen Yousuf, MD, at (773) 702-6003.
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