To ensure the scientific and recognized evaluation of patient-centered clinical research outcomes, the drug development tool qualification certification website of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have disclosed the information of clinical outcome assessment (COA) submitted for certification, and encouraged the use of certified COA. This paper searched all COA and approval decisions on the website, analyzed the submitted information and certification status of COA, and interpreted the certification technology and process of COA, so as to provide references and suggestions for the development of patient-centered clinical research outcome evaluation.
ObjectiveTo explore the application value of high intensity focused ultrasound (HIFU) in the treatment of advanced pancreatic cancer.MethodThe domestic and foreign literatures about studies of HIFU treating advanced pancreatic cancer in recent years were retrieved and summarized.ResultsHIFU could prolong the survival time, control pain, and enhance the body’s immune function in patients with advanced pancreatic cancer. There were no obvious serious complications during the treatment process. The combined treatment with radiotherapy, chemotherapy, and traditional Chinese medicine could obviously prolong the survival time and improve the quality of life for the patients with advanced pancreatic cancer.ConclusionsHIFU is an important component in the comprehensive treatment of advanced pancreatic cancer. However, because there is no uniform standard for the dosage of HIFU treatment, the sample size of many related studies is small, so the research results have certain limitations, so more studies are needed to improve their understanding of advanced pancreatic cancer in order to better serve clinical workin future.
Objective To explore the effectiveness and appropriate energy parameters of high-intensity focused ultrasound (HIFU) in treating infant hemangiomas. Methods Between January 2009 and September 2010, 60 infants with hemangioma were treated. There were 23 boys and 37 girls, aged from 3 to 30 months with an average of 10 months. These hemangiomas were located at head and face (24 cases), trunk (15 cases), l imb (16 cases), buttocks (2 cases), perineum (1 case),and multiple lesions (cervix, abdomen, and upper l imbs, 2 cases). The size of hemangiomas ranged from 0.8 cm × 0.6 cm to 6.0 cm × 5.0 cm. The 60 infants were randomly divided into 3 groups: groups A, B, and C (n=20) based on different ultrasound energies used in treatment. The lesion surface was irradiated with 3-5 mm/second for 5 continuously by ultrasonic therapeutic apparatus at a frequency of 9 MHz, impulse of 1 000, and 10% of scanning overlap; the powers of 3.5, 4.0, and 4.5 W were used in groups A, B, and C, respectively, 3 times as a course of treatment with 1 month interval. The effect and ulcer and scar risk in irradiation region were observed after 6 months of treatment. Results All cases were treated for one course. After 6 months of treatment, no significant difference in the effect was found among 3 groups based on hemangioma treatment judging criterion (P gt; 0.05). Neither ulcer nor scar occurred in group A; ulcer occurred in 4 cases (20%) of group B with superficial scars, and in 7 cases (35%) of group C with obvious scars. The rates of ulcer and scar in groups B and C were significantly higher than that in group A (P lt; 0.05). Conclusion HIFU irradiating is one of effective methods for treating infant hemangioma, but the appropriate energy was below 3.5 W.
Epilepsy, as a common neurological disorder in childhood, requires early diagnosis and intervention that are crucial for improving disease prognosis. Although traditional techniques such as electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) have made progress in pediatric epilepsy diagnosis and treatment, significant limitations remain in imaging-negative cases and in identifying deep lesions. Magnetoencephalography (MEG), a non-invasive neurophysiological technique with both high temporal and spatial resolution, has recently demonstrated unique advantages in localizing epileptogenic zones, analyzing functional connectivity, and identifying brain functional areas in children with epilepsy. In particular, the next-generation MEG systems based on optically pumped magnetometers (OPMs) have significantly broadened its applicability in pediatric populations. Nonetheless, practical use of OPM-MEG remains hindered by challenges such as non-standardized signal processing workflows, lack of agreement on dependable electrophysiological biomarkers, and the relatively high cost of devices. In the future, with continuous advances in multimodal integration, wearable device incorporation, and AI-assisted analysis, MEG is expected to achieve broader application in pediatric epilepsy diagnosis and treatment.
bjectiveTo evaluate the efficacy and limits of high intensity focused ultrasound (HIFU) in tumor treatment. MethodsThe references about the application of HIFU in tumor treatment in recent years were reviewed.ResultsHIFU caused localized hyperthermia at predictable depth in a few seconds to make the tumor tissue coagulative necrosis without injuring surrounding tissue. HIFU treatment had the advantages of low morbidity, noninvasiveness, avoidance of systemic side effects, and repeatitiveness. However, the utilization of HIFU sometimes could be limited by some factors such as imaging technique, organ movement, incomplete tissue destruction, etc.ConclusionHIFU is a promising noninvasive therapy for tumor treatment, though there are lots of problems to be further studied.
Objective To study the mechanism of high intensity focused ultrasound (HIFU) and discuss its clinical significance in the treatment of mid-late stage liver cancer. Methods The patients with mid-late stage liver cancer were treated with HIFU. The changes of photography, pathology and immunology after operation were evaluated. Results It was shown that the results of the photographic, pathologic and immunologic examinations changed during the treatment of the patients with HIFU. Conclusion HIFU is effective and safe for the treatment of mid-late stage liver cancer.
Numerical simulation is one of the most significant methods to predict the temperature distribution in high-intensity focused ultrasound (HIFU) therapy. In this study, the adopted numerical simulation was used based on a transcranial ultrasound therapy model taking a human skull as a reference. The approximation of the Westervelt formula and the Pennes bio-heat conduction equation were applied to the simulation of the transcranial temperature distribution. According to the temperature distribution and the Time Reversal theory, the position of the treatable focal region was corrected and the hot spot existing in the skull was eliminated. Furthermore, the influence of the exposure time, input power and the distance between transducer and skull on the temperature distribution was analyzed. The results showed that the position of the focal region could be corrected and the hot spot was eliminated using the Time Reversal theory without affecting the focus. The focal region above 60℃ could be formed at the superficial tissue located from the skull of 20 mm using the hot spot elimination method and the volume of the focal region increases with the exposure time and the input power in a nonlinear form. When the same volume of the focal region was obtained, the more power was inputted, the less the exposure time was needed. Moreover, the volume of the focal region was influenced by the distance between the transducer and the skull.
ObjectiveTo probe into the clinical efficacy of high-intensity focused ultrasound (HIFU) alone for uterine fibroids. MethodBetween February 2012 and February 2014, 145 patients with 174 cases of uterine fibroids were treated with HIFU. Before and one day, 6 months, 12 months after treatment, MRI was performed during the follow-up. We analyzed fibroids narrowing rate, adverse reactions, and clinical symptoms improvement after treatment. ResultsSuccessful completion of HIFU ablation was done for all the fibroids. Enhanced MRI examination before and one day after treatment, and MRI plain scanning 6 and 12 months after treatment showed that fibroid volume before treatment was 4.61-419.70 cm3 (median of 56.82 cm3), fibroid volume after treatment was 3.02-578.21 cm3 (median of 56.74 cm3), ablation volume was 2.42-578.21 cm3 (median of 47.84 cm3), and volumetric ablation rate was 24%-100%; there was no statistically significant difference in fibroid volume before and after treatment (P>0.05); fibroid volume 6 months after treatment was 0-264.50 cm3 (median of 22.49 cm3) and was 0-346.02 cm3 (median of 14.81 cm3) 12 months after treatment with a reduction rate of 60.4% and 73.9% on average respectively, and the volume was significantly different between those two time points and before treatment (P<0.05), and between 6 months and 12 months after treatment (P<0.05). The medians of uterine fibroid symptoms (UFS) and quality of life (QOL) scores before ablation were respectively 21.88 and 71.55 points. UFS reduced by 57.1% and 71.4% respectively 6 and 12 months after ablation, and QOL increased by 15.7% and 26.5% at those two time points. Both UFS and QOL 6 and 12 months after treatment were significantly different from that before treatment (P<0.05), and the UFS and QOL difference between 6 months and 12 months after treatment was also significant (P<0.05). As time went on, UFS gradually reduced, while QOL gradually increased. Complication rate was 2.8% with two cases of skin shallow degree-Ⅱ thermal damage, one of lower limb radiation pain, one of urinary retention, and there were 6 cases of recurrence during the follow-up. ConclusionsHIFU treatment for uterine fibroids is safe and effective, and is an alternative choice for conventional treatment when it is unable to retain the womb or when the patient refuses surgical treatment.
A miniaturized, low-cost high-intensity focused ultrasound device is developed for the problems of cross-contamination and uneven sample fragmentation in conventional ultrasound devices. This device generates ultrasonic waves through a concave spherical self-focusing piezoelectric ceramic piece, and creates a cavitation effect in the focusing area to achieve sample fragmentation. The feasibility of the device is demonstrated by physical simulation, then a driving circuit with adjustable power is designed and manufactured to generate 0 ~ 22.4 W acoustic power, and finally paraffin-embedded sample dewaxing experiments are performed to verify the validation of the device. The experimental results show that the dewaxing efficiency and safety of the high-intensity focused ultrasound device is significantly better than those of traditional chemical methods, and this device is comparable with commercial ultrasonic instruments. In summary, the high-intensity focused ultrasound device is expected to be applied in automated nucleic acid extraction and purification equipment and has a broad application prospect in the field of sample pre-processing.
Epilepsy is a clinical syndrome characterized by recurrent epileptic seizures caused by various etiologies. Etiological diagnosis and localization of the epileptogenic focus are of great importance in the treatment of epilepsy. Positron emission tomography-computed tomography (PET-CT) technology plays a significant role in the etiological diagnosis and localization of the epileptogenic focus in epilepsy. It also guides the treatment of epilepsy, predicts the prognosis, and helps physicians intervene earlier and improve the quality of life of patients. With the continuous development of PET-CT technology, more hope and better treatment options will be provided for epilepsy patients. This article will review the guiding role of PET-CT technology in the diagnosis and treatment of epilepsy, providing insights into its application in etiological diagnosis, preoperative assessment of the condition, selection of treatment plans, and prognosis of epilepsy.