Trial Title:
The Clinical Application of Ultramicro-flow Technique in the Treatment of Benign Uterine Tumors With High-intensity Focused Ultrasound
NCT ID:
NCT06435663
Condition:
Patients With Uterine Fibroids Receiving HIFUA Treatment ,and Can Undergo Regular Follow-up
Conditions: Official terms:
Leiomyoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Different methods of efficacy evaluation
Description:
When the treatment method remains unchanged, compare the accuracy data of the
effectiveness evaluation between the two groups, and verify that the ultra-fine blood
flow imaging technology (SMI) is superior to the organ contrast-enhanced ultrasound
evaluation method in the efficacy evaluation after HIFUA treatment.
Arm group label:
control group
Arm group label:
experimental group
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。
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. 1.5 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 (cm3)=left
and right diameter (cm) X anterior and posterior diameter (cm) X long diameter (cm) X
0.523, ablation rate=volume of non perfused area after treatment/volume of uterine
fibroids before treatment X 100%, volume reduction rate=(volume of uterine fibroids
before treatment - volume of uterine fibroids after 3.6.12 months after treatment)/volume
of uterine fibroids before treatment X 100%. Ablation rate of 70% is considered
satisfactory, 50% V ablation rate<70% 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. 1.5 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 (cm3)=left
and right diameter (cm) X anterior and posterior diameter (cm) X long diameter (cm) X
0.523, ablation rate=volume of non perfused area after treatment/volume of uterine
fibroids before treatment X 100%, volume reduction rate=(volume of uterine fibroids
before treatment - volume of uterine fibroids after 3.6.12 months after treatment)/volume
of uterine fibroids before treatment X 100%. Ablation rate of 70% is considered
satisfactory, 50% V ablation rate<70% 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
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Agency class:
Other
Source:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435663
