Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: SkinScan3D camera.
- Кому может быть актуально
- Состояния в реестре: Kaposi Sarcoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
While tremendous progress has been made against HIV, both in preventing the infection and in treating AIDS, the disease it causes, AIDS-related malignancies like Kaposi sarcoma (KS) remain a significant health burden, in both the U.S. and especially the developing world. In many cases, multiple KS lesions develop simultaneously, and may progress and regress independently. Photographs are an essential part of the evaluation for KS, as reflected in their formal usage described in the KS Tumor Assessment Manual of Procedures. However, acquiring a clear, informative photo is not trivial, since anatomy is 3D and conventional imaging is 2D. The importance of accurate, quantitative 3D information is especially pronounced for the treatment of KS because when a tumor responds positively to treatment, the initial change is usually a flattening of the lesion, without any significant change in the projected 2D area. To evaluate the vertical space, along with other characteristics of a KS lesion, we have created an innovative imaging system, SkinScan3D, utilizing new commercial liquid lens technologies and AI based image analysis software, with strategies borrowed from astronomical imaging techniques previously used on NASA space telescopes. In this study, the investigators will develop and demonstrate a protocol for recording measurable 3D parameters, which may be used in a longitudinal study to rigorously monitor therapeutic responses of KS and statistically compare with that of the conventional AMC criteria.
Вмешательства
- Устройство SkinScan3D camera
The SkinScan3D (SS3D) is a portable, battery-powered imaging prototype which can successfully achieve all-focus, 3D images using low-cost, off-the-shelf components.
Первичные конечные точки
- Rate of successful capture of high-quality 3D images of cutaneous KS lesions [Срок оценки: Baseline and up to 12 additional visits, each visit will take approximately 30 minutes (estimated to be 12 months)]
- Time to detect response or failure to treatment (Cohort B only) [Срок оценки: Baseline and up to 12 additional visits, each visit will take approximately 30 minutes (estimated to be 12 months)]
Критерии участия
Eligibility Criteria:
- Have been diagnosed with histologically or cytologically proven Kaposi sarcoma (KS).
- Patients may be off treatment or on treatment for their KS.
- Has at least 3 cutaneous Kaposi sarcoma lesions.
- At least 18 years of age.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Washington University School of Medicine — St Louis
Идентификаторы
NCT: NCT06751355 · 202501193 · U01CA292765