Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435663
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-26
Brief Title:
The Clinical Application of Ultramicro-flow Technique in the Treatment of Benign Uterine Tumors With High-intensity Focused Ultrasound
Sponsor:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Organization:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study Overview
Official Title:
Fellow Docotor Masters Degree
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Research object All adult patients diagnosed with uterine fibroids or adenomyosis admitted to our hospital from May 2024 to December 2024
Inclusion criteria Patients with clinically diagnosed uterine fibroids or adenomyosis who meet the following conditions 1 Imaging shows that the uterine fibroids are located between the muscle walls or are pedunculated subserosal or submucosal fibroids which are classified as types 2-6 by the International Federation of Gynecology and Obstetrics FIGO The diagnosis of adenomyosis is clear 2 The imaging shows that there is no intestinal obstruction between uterine fibroids or adenomyosis and the abdominal wall or the impact of intestinal obstruction can be eliminated through treatment making it a safe treatment path 3 Abdominal subcutaneous fat thickness 4 cm 4 The farthest distance from the abdominal wall skin to the target area for treating fibroids is 14 cm 5 The patient is generally in good condition and can tolerate and maintain a prone position for 2 hours or longer 6 Adult and infertile women
Exclusion criteria
1 Unclear clinical diagnosis 2 Uterine fibroids or adenomyosis rapidly increase in the short term or imaging suggests a tendency for malignancy or the malignant potential is uncertain 3 Acute skin infection in the treatment area 4 Uncontrolled acute pelvic inflammatory disease 5 The general condition is poor with severe dysfunction of important organs such as the heart liver and kidneys 6 Severe coagulation dysfunction 7 There are large skin scars in the treatment area of the lower abdomen 8 Sedative and analgesic drugs cannot be used 9 Postmenopausal enlarged uterine fibroids or adenomyosis 10 Pregnant women individuals with mental disorders cognitive impairments etc who are unable to cooperate with treatment
Materials and Methods Experimental materials
1 Haiying HY2900 ultrasound focusing equipment Wuxi Haiying Medical Technology Co Ltd Toshiba Aplio i800 color ultrasound diagnostic instrument Toshiba Medical Systems Co Ltd equipped with SMI imaging software convex array probe frequency 1-6MHz using color mode ultra fine vessel imaging eSMI
2 The contrast agent used is sulfur hexafluoride microbubbles for injection Shanghai Bolaike Xinyi Pharmaceutical Co Ltd
Research methods
Randomly group the included subjects
1 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 modes were used to observe the blood supply within the lesion which were classified into 4 levels according to Adler grading criteria 0 level with no blood flow signal inside the fibroid Grade 1 with a small amount of blood flow signal within the fibroid with 1-2 short rod-shaped blood flows visible Level 2 moderate to equal blood flow signal with one clear blood vessel visible within the fibroid with a length exceeding the lesion radius or 3-4 short rod-shaped blood flow signals visible Level 3 rich blood flow with 4 or more blood vessels visible within the fibroid The surrounding blood vessels of the fibroid form a network around the entire fibroid presenting a ball hugging sign or have multiple branching branches extending into the fibroid interweaving into a network or patchy pattern Detect hemodynamic parameters including peak systolic velocity PSV and resistance index RD and compare hemodynamic data to calculate the effectiveness of changes in uterine benign tumor physical examination after treatment
2 Control group In HIFUA treatment organ ultrasound contrast evaluation technology was used for efficacy evaluation Sono Vue Bracco company was used as the contrast agent Before use 5 ml of physiological saline was injected into the bottle vigorously shaken until the freeze-dried powder was completely dispersed 15 ml of contrast agent was 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 The CEUS enhancement degree of uterine fibroids can be divided into high enhancement the enhancement degree is higher than that of the uterine muscle layer Equal enhancement The degree of enhancement is equal to the uterine muscle layer Low enhancement The degree of enhancement is lower than that of the uterine muscle layer 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
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
Efficacy evaluation Calculate the volume of uterine fibroids before treatment ablation rate and volume reduction rate at 3 months 6 months and 12 months Volume cm3left and right diameter cm X anterior and posterior diameter cm X long diameter cm X 0523 ablation ratevolume of non perfused area after treatmentvolume of uterine fibroids before treatment X 100 volume reduction ratevolume of uterine fibroids before treatment - volume of uterine fibroids after 3612 months after treatmentvolume of uterine fibroids before treatment X 100 Ablation rate of 70 is considered satisfactory 50 V ablation rate70 is partial ablation and ablation rate V 5 less than 50 is considered ineffective SMI evaluates the blood flow signal inside uterine fibroids Level 0 indicates satisfactory ablation level 1 indicates partial ablation and levels 2-3 indicate ineffective ablation 2 Control group In HIFUA treatment organ ultrasound contrast evaluation technology was used for efficacy evaluation Sono Vue Bracco company was used as the contrast agent Before use 5 ml of physiological saline was injected into the bottle vigorously shaken until the freeze-dried powder was completely dispersed 15 ml of contrast agent was 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 The CEUS enhancement degree of uterine fibroids can be divided into high enhancement the enhancement degree is higher than that of the uterine muscle layer Equal enhancement The degree of enhancement is equal to the uterine muscle layer Low enhancement The degree of enhancement is lower than that of the uterine muscle layer 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
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
Efficacy evaluation Calculate the volume of uterine fibroids before treatment ablation rate and volume reduction rate at 3 months 6 months and 12 months Volume cm3left and right diameter cm X anterior and posterior diameter cm X long diameter cm X 0523 ablation ratevolume of non perfused area after treatmentvolume of uterine fibroids before treatment X 100 volume reduction ratevolume of uterine fibroids before treatment - volume of uterine fibroids after 3612 months after treatmentvolume of uterine fibroids before treatment X 100 Ablation rate of 70 is considered satisfactory 50 V ablation rate70 is partial ablation and ablation rate V 5 less than 50 is considered ineffective SMI evaluates the blood flow signal inside uterine fibroids Level 0 indicates satisfactory ablation level 1 indicates partial ablation and levels 2-3 indicate ineffective ablation
Inclusion criteria Patients with clinically diagnosed uterine fibroids or adenomyosis who meet the following conditions 1 Imaging shows that the uterine fibroids are located between the muscle walls or are pedunculated subserosal or submucosal fibroids which are classified as types 2-6 by the International Federation of Gynecology and Obstetrics FIGO The diagnosis of adenomyosis is clear 2 The imaging shows that there is no intestinal obstruction between uterine fibroids or adenomyosis and the abdominal wall or the impact of intestinal obstruction can be eliminated through treatment making it a safe treatment path 3 Abdominal subcutaneous fat thickness 4 cm 4 The farthest distance from the abdominal wall skin to the target area for treating fibroids is 14 cm 5 The patient is generally in good condition and can tolerate and maintain a prone position for 2 hours or longer 6 Adult and infertile women
Exclusion criteria
1 Unclear clinical diagnosis 2 Uterine fibroids or adenomyosis rapidly increase in the short term or imaging suggests a tendency for malignancy or the malignant potential is uncertain 3 Acute skin infection in the treatment area 4 Uncontrolled acute pelvic inflammatory disease 5 The general condition is poor with severe dysfunction of important organs such as the heart liver and kidneys 6 Severe coagulation dysfunction 7 There are large skin scars in the treatment area of the lower abdomen 8 Sedative and analgesic drugs cannot be used 9 Postmenopausal enlarged uterine fibroids or adenomyosis 10 Pregnant women individuals with mental disorders cognitive impairments etc who are unable to cooperate with treatment
Materials and Methods Experimental materials
1 Haiying HY2900 ultrasound focusing equipment Wuxi Haiying Medical Technology Co Ltd Toshiba Aplio i800 color ultrasound diagnostic instrument Toshiba Medical Systems Co Ltd equipped with SMI imaging software convex array probe frequency 1-6MHz using color mode ultra fine vessel imaging eSMI
2 The contrast agent used is sulfur hexafluoride microbubbles for injection Shanghai Bolaike Xinyi Pharmaceutical Co Ltd
Research methods
Randomly group the included subjects
1 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 modes were used to observe the blood supply within the lesion which were classified into 4 levels according to Adler grading criteria 0 level with no blood flow signal inside the fibroid Grade 1 with a small amount of blood flow signal within the fibroid with 1-2 short rod-shaped blood flows visible Level 2 moderate to equal blood flow signal with one clear blood vessel visible within the fibroid with a length exceeding the lesion radius or 3-4 short rod-shaped blood flow signals visible Level 3 rich blood flow with 4 or more blood vessels visible within the fibroid The surrounding blood vessels of the fibroid form a network around the entire fibroid presenting a ball hugging sign or have multiple branching branches extending into the fibroid interweaving into a network or patchy pattern Detect hemodynamic parameters including peak systolic velocity PSV and resistance index RD and compare hemodynamic data to calculate the effectiveness of changes in uterine benign tumor physical examination after treatment
2 Control group In HIFUA treatment organ ultrasound contrast evaluation technology was used for efficacy evaluation Sono Vue Bracco company was used as the contrast agent Before use 5 ml of physiological saline was injected into the bottle vigorously shaken until the freeze-dried powder was completely dispersed 15 ml of contrast agent was 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 The CEUS enhancement degree of uterine fibroids can be divided into high enhancement the enhancement degree is higher than that of the uterine muscle layer Equal enhancement The degree of enhancement is equal to the uterine muscle layer Low enhancement The degree of enhancement is lower than that of the uterine muscle layer 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
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
Efficacy evaluation Calculate the volume of uterine fibroids before treatment ablation rate and volume reduction rate at 3 months 6 months and 12 months Volume cm3left and right diameter cm X anterior and posterior diameter cm X long diameter cm X 0523 ablation ratevolume of non perfused area after treatmentvolume of uterine fibroids before treatment X 100 volume reduction ratevolume of uterine fibroids before treatment - volume of uterine fibroids after 3612 months after treatmentvolume of uterine fibroids before treatment X 100 Ablation rate of 70 is considered satisfactory 50 V ablation rate70 is partial ablation and ablation rate V 5 less than 50 is considered ineffective SMI evaluates the blood flow signal inside uterine fibroids Level 0 indicates satisfactory ablation level 1 indicates partial ablation and levels 2-3 indicate ineffective ablation 2 Control group In HIFUA treatment organ ultrasound contrast evaluation technology was used for efficacy evaluation Sono Vue Bracco company was used as the contrast agent Before use 5 ml of physiological saline was injected into the bottle vigorously shaken until the freeze-dried powder was completely dispersed 15 ml of contrast agent was 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 The CEUS enhancement degree of uterine fibroids can be divided into high enhancement the enhancement degree is higher than that of the uterine muscle layer Equal enhancement The degree of enhancement is equal to the uterine muscle layer Low enhancement The degree of enhancement is lower than that of the uterine muscle layer 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
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
Efficacy evaluation Calculate the volume of uterine fibroids before treatment ablation rate and volume reduction rate at 3 months 6 months and 12 months Volume cm3left and right diameter cm X anterior and posterior diameter cm X long diameter cm X 0523 ablation ratevolume of non perfused area after treatmentvolume of uterine fibroids before treatment X 100 volume reduction ratevolume of uterine fibroids before treatment - volume of uterine fibroids after 3612 months after treatmentvolume of uterine fibroids before treatment X 100 Ablation rate of 70 is considered satisfactory 50 V ablation rate70 is partial ablation and ablation rate V 5 less than 50 is considered ineffective SMI evaluates the blood flow signal inside uterine fibroids Level 0 indicates satisfactory ablation level 1 indicates partial ablation and levels 2-3 indicate ineffective ablation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None