Fellow Docotor, Master's Degree

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

High intensity focused ultrasound ablation (HIFUA) is a new non-invasive treatment method for uterine tumors. Traditionally, nuclear magnetic resonance imaging (NMRI), also known as magnetic resonance imaging (MRI), is used as guidance to focus ultrasound on the fibroid tissue, generating high temperatures of 65-85 ℃, causing protein inactivation, cell apoptosis, and coagulation necrosis of tumor cells. While accurately ablating fibroid tissue, it avoids damaging normal tissue outside the treatment area. Since 2000, a large number of clinical studies have demonstrated the safety and effectiveness of MRI for HIFUA in the treatment of uterine fibroids. In 2013, the Chinese FDA approved MRI guided HIFUA treatment for uterine fibroids. At present, more and more medical institutions in China have introduced this device and carried out non-invasive treatment of uterine fibroids. In March 2020, the Minimally Invasive Treatment Group of the Magnetic Resonance Application Professional Committee of the China Medical Equipment Association designated the Chinese Expert for MRI Guided Focused Ultrasound Treatment of Uterine Fibroids, making HIFUA more standardized. Superb micro vascular imaging (SMI) is an improved Doppler technology that applies a new adaptive algorithm to remove tissue motion signals and blood flow overflow phenomena, and can clearly display the extremely low velocity blood flow inside the blood vessels. Previous studies have shown that SMI has a significantly higher ability to detect blood vessels in tumors than color Doppler flow imaging (CDFI), and can more sensitively detect the blood flow of microvessels within tumors. This provides a cheap and simple non-invasive examination method for clinical practice, and real-time guidance for treatment can be provided during the treatment process, making it easy to operate and promote in clinical practice. This study randomly divided all adult patients diagnosed with uterine fibroids or adenomyosis admitted to our hospital from May 2024 to December 2024 into two groups based on the inclusion and exclusion of specimens: 1) Experimental group: HIFUA treatment, treatment efficacy evaluation using SMI technology; control group: HIFUA treatment, treatment efficacy evaluation using organ contrast-enhanced ultrasound technology. Both groups of subjects need to be followed up: at 3 months, 6 months, and 12 months after treatment, patients will undergo gynecological uterine ultrasound examination at the outpatient department, and the volume of uterine fibroids or adenomyosis will be recorded. The aim of this study is to compare the accuracy data of two groups in evaluating treatment effectiveness, and to verify that ultra-fine blood flow imaging (SMI) technology is superior to organ contrast-enhanced ultrasound in evaluating the efficacy of HIFUA treatment。

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
Locations
Other Locations
China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Yiwu
Contact Information
Primary
Yu Zhang
jigoulunli_zy4y@163.com
+86 0579-89935052
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Active_comparator: experimental group
In HIFUA treatment, SMI technology was used to evaluate the therapeutic effect. The SMI technology used Toshiba Aplio 800 color ultrasound diagnostic instrument, equipped with SMI imaging software, convex array probe, frequency 1-6 MHz, and color mode ultra fine vessel imaging (eSMI). After the target lesion is determined by abdominal scanning, adjust the depth and gain, and record the number, location, size, shape and boundary of the lesion. CDFI and eSMI models were used to observe the blood supply within the lesion, which were divided into four levels according to Adler grading criteria. Hemodynamic parameters were measured, including peak systolic velocity (PSV) and resistance index (RD). Hemodynamic data were compared to calculate the effectiveness of changes in uterine benign tumor examination after treatment.
Other: control group
In HIFUA treatment, organ ultrasound contrast evaluation technology is used for efficacy evaluation. Sono Vue (Bracco company) is used as the contrast agent. Before use, 5 ml of physiological saline is injected into the bottle, vigorously shaken until the freeze-dried powder is completely dispersed. 1.5 ml of contrast agent is extracted and rapidly injected through the anterior elbow vein, followed by 5 ml of physiological saline injection. After injecting contrast agent, start the timer at the same time, observe under ultrasound imaging, keep the probe stationary during examination, observe continuously for 2 minutes, and store dynamic images. Calculate the effective rate of physical examination changes in benign uterine tumors after treatment by displaying ablation volume through contrast-enhanced ultrasound before and after treatment.
Related Therapeutic Areas
Sponsors
Leads: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov