Multimodal Ultrasound Imaging Assessment on Keloid

Study Overview
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Brief Summary
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Skin keloids are common dermatological conditions that can lead to physical limitations, functional impairments, and deformities. Beyond the physiological implications, the aesthetic ramifications of keloids can also result in significant psychological distress, including anxiety and depression, causing both physical and emotional suffering to the affected individuals. The incidence of keloids is high, characterized by their chronicity, resistance to treatment, and high recurrence rate. They have become one of the most challenging conditions to treat across burn surgery, plastic surgery, and dermatology disciplines. The lack of standardized clinical treatment guidelines globally, combined with an absence of a well-defined standardized evaluation system, means that the effectiveness of various treatments is not consistently and objectively assessed, creating significant challenges in clinical applications. This project integrates traditional high-frequency ultrasound with cutting-edge technologies like real-time shear wave elastography and ultra-micro blood flow imaging. By using multimodal ultrasound, investigators aim to observe the therapeutic response of 90Sr-90Y patch treatment on skin keloids. Investigators seek to determine the objectivity and quantification role of multimodal ultrasound data and indicators in assessing keloid severity, including blood flow information and elasticity hardness. Another goal is to obtain quantitative data on keloid thickness, volume, stiffness, and microvascular distribution before and after treatment to monitor the therapy response. This would address the current limitations of subjective keloid scoring scales. It would also serve as an objective assessment standard for precise diagnosis, treatment, and follow-up of keloids in a clinical setting, thereby standardizing the clinical diagnosis and treatment of keloids.

Detailed Description
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Currently, no one-size-fits-all approach exists and a universally accepted, standardized evaluation and treatment protocol remains elusive, making it challenging to determine which method is the most effective. Commonly used methods for assessing keloids, such as the Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessment Scale (POSAS), rely heavily on subjective evaluations based on observer perception and patient-reported experiences. These methods lack objective quantitative evaluation indicators and the ability to visualize subcutaneous tissues, limiting their individual clinical applicability. The Vancouver Scar Scale (VSS) is the most established questionnaire used for the evaluation of pathological scarring. This scale evaluates aspects of scar vascularity, pigmentation, pliability, and height, with the scoring system ranging from 0 to 15, where 0 is the least severe and 15 is the most severe. In the study, keloids were classified into three categories based on the VSS score: mild (0-5), moderate (6-9), and severe (10-15).

Official Title
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A Prospective, Longitudinal, Intraindividual Clinical Study in Keloid With Multimodal Ultrasound Assessment

Conditions
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Keloid

Intervention / Treatment
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* Diagnostic Test: multimodal ultrasound
* Radiation: radioisotope applicator therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 16 years and above Outpatients with no received any treatment in previous 6 months Willing to participate in this trial and have signed an informed consent form Exclusion Criteria: Pregnant or breastfeeding women patients with malignant tumors, hypertension, diabetes, skin rupture, skin infection which may influence keloid healing and other dermatologic diseases

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| good response group of treated keloids<br>The Vancouver Scar Scale (VSS) is the most established questionnaire used for the evaluation of pathological scarring. This scale evaluates aspects of scar vascularity, pigmentation, pliability, and height, with the scoring system ranging from 0 to 15, where 0 is the least severe and 15 is the most severe.All the keloids in the study were classified into three categories based on the VSS score: mild (0-5), moderate (6-9), and severe (10-15). For treatment assessment, investigators further divided the treated participants into two groups: a good response group (showing an improvement of 5 or more points in the VSS score) and a poor response group (less than 5 points improvement in the VSS score) | Diagnostic Test: multimodal ultrasound<br>* An Aixplorer ultrasound machine (SuperSonic Imaging, Ltd, Aixen-Provence, France), equipped with AngioPLUS(AP) and shear wave elastography(SWE) functions, was used for all examinations using a 4-15MHz linear probe.AP function can detect microvessels of lesions,SWE can evaluate the stiffness of lesions and high frequency ultrasound can measure the thickness and volume of keloid.<br>Radiation: radioisotope applicator therapy<br>* The radioisotope applicator therapy utilized 90Sr-90Y(0094SR814975) isotope, customized by the China Atomic Energy Research Institute. The element therapy instrument used had overall dimensions of 2.8cm x 2.8cm, with an effective treatment area of 2.0cm x 2.0cm. It delivered a radiation dose of 5.0Gy/h. Each patient received superficial radiation therapy through a single 90Sr source, administered in repeated doses. The isotope therapy instrument was customized to fit the exact size of the keloid, ensuring coverage the irradiation range extending 0.5cm beyond the keloid's edge. During treatment, the surface of the applicator was aligned with the irradiated area and directly contact the surface of the keloid tissue. The treatment was carried out low-dose irradiation method, over 5 sessions, with each session delivering a dose of 2Gy. Each irradiation lasted for 25min.<br>|
| poor response group of treated keloids<br>The Vancouver Scar Scale (VSS) is the most established questionnaire used for the evaluation of pathological scarring. This scale evaluates aspects of scar vascularity, pigmentation, pliability, and height, with the scoring system ranging from 0 to 15, where 0 is the least severe and 15 is the most severe. All the keloids in the study keloids were classified into three categories based on the VSS score: mild (0-5), moderate (6-9), and severe(10-15). For treatment assessment, investigators further divided the treated participants into two groups: a good response group (showing an improvement of 5 or more points in the VSS score) and a poor response group (less than 5 points improvement in the VSS score) | Diagnostic Test: multimodal ultrasound<br>* An Aixplorer ultrasound machine (SuperSonic Imaging, Ltd, Aixen-Provence, France), equipped with AngioPLUS(AP) and shear wave elastography(SWE) functions, was used for all examinations using a 4-15MHz linear probe.AP function can detect microvessels of lesions,SWE can evaluate the stiffness of lesions and high frequency ultrasound can measure the thickness and volume of keloid.<br>Radiation: radioisotope applicator therapy<br>* The radioisotope applicator therapy utilized 90Sr-90Y(0094SR814975) isotope, customized by the China Atomic Energy Research Institute. The element therapy instrument used had overall dimensions of 2.8cm x 2.8cm, with an effective treatment area of 2.0cm x 2.0cm. It delivered a radiation dose of 5.0Gy/h. Each patient received superficial radiation therapy through a single 90Sr source, administered in repeated doses. The isotope therapy instrument was customized to fit the exact size of the keloid, ensuring coverage the irradiation range extending 0.5cm beyond the keloid's edge. During treatment, the surface of the applicator was aligned with the irradiated area and directly contact the surface of the keloid tissue. The treatment was carried out low-dose irradiation method, over 5 sessions, with each session delivering a dose of 2Gy. Each irradiation lasted for 25min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stiffness measured by SWE | The difference of stiffness in good response group and poor response group | from baseline to 6 months | 
| Change in microvessel signal grade measured by AP | The difference of microvessel signal grade in good response group and poor response group | from baseline to 6 months | 
| Change in thickness measured by high frequency ultrasound | The difference of thickness in good response group and poor response group | from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multimodal ultrasound, shear wave elastography, microvessel imaging