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Идёт набор NCT07037966

Advancing Portable Brain Imaging: The NextMRI Project's Role in Revolutionizing Diagnostic MRI

Без фазы С лечением Multiple Sclerosis

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: MRI, MRI.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: 18 лет — 65 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Truly Portable MRI for Extremity and Brain Imaging Anywhere & Everywhere

Обзор

Mobile imaging diagnostic devices are extremely valuable for clinical diagnosis both inside and outside healthcare facilities. However, Magnetic Resonance Imaging (MRI)-the gold standard for diagnosing many neurological and musculoskeletal conditions-is not easily portable. Moreover, due to its high cost (in the million-euro range) and limited availability, the average wait time in Europe for an MRI scan is from several weeks to months. The NextMRI project aims to take the technical, industrial, and commercial steps required to deploy portable low-field MRI systems in remote and developing regions, rural areas, sporting events, military or medical camps, and home healthcare settings, improving diagnostic capabilities. The specific goals of the NextMRI project are: 1. Expand current low-field MRI technology to brain imaging. 2. Enhance diagnostic accuracy using machine learning. 3. Improve portability and usability for end users. 4. Reduce production costs for broader affordability. 5. Collect clinical evidence through trials to validate medical performance. 6. Develop a sustainable business model for market commercialization.

Подробное описание

Based on this context, the NextMRI project will carry out a clinical evaluation study involving a multidisciplinary team of radiologists, rheumatologists, physiotherapists, data managers, and physicists. The study will focus on patients with suspected multiple sclerosis (MS). Its main goals are to:

1. Assess the diagnostic value of the low-field MRI prototype. 2. Evaluate usability for end users. 3. Train AI algorithms using deep learning to differentiate between healthy and damaged tissues, thereby aiding radiologists, reducing diagnostic time, and lightening their workload.

Radiologists will first generate structured reports based on standard high-resolution MRI scans. They will then evaluate the low-field MRI images from the NextMRI prototype. The initial high-field MRI reports will serve as the reference standard for assessing performance and training the AI system.

Each patient will undergo two MRI scans on the same day (after providing informed consent): one at the standard 3T MR scan and other at the low-field MRI scan (NextMRI). To prevent bias, both scans will be interpreted by a professional radiologist with an 8-week interval between readings.

A total of 50 patients aged between 18 and 65 years with suspected multiple sclerosis will be included. Patients with any contraindications for high-field MRI will be excluded from the study.

Вмешательства

  • Устройство MRI
    Standard 3T MRI Scan
  • Устройство MRI
    Low-field MRI scan using the NextMRI prototype

Первичные конечные точки

  • Radiological reports to Evaluate NextMRI prototype performance [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (2)
  • Patient Comfort and Satisfaction Questionnaire to Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner [Срок оценки: 1 year]
  • User Comfort and Satisfaction Questionnaire Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients with suspected multiple sclerosis

Критерии исключения

  • Any contradictions for high-field MRI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Испания · 1 центр
  • Hospital Universitario y Politécnico la Fe — Valencia

Публикации

  • Guallart-Naval T, Algarin JM, Pellicer-Guridi R, Galve F, Vives-Gilabert Y, Bosch R, Pallas E, Gonzalez JM, Rigla JP, Martinez P, Lloris FJ, Borreguero J, Marcos-Perucho A, Negnevitsky V, Marti-Bonmati L, Rios A, Benlloch JM, Alonso J. Portable magnetic resonance imaging of patients indoors, outdoors and at home. Sci Rep. 2022 Jul 30;12(1):13147. doi: 10.1038/s41598-022-17472-w. PMID 35907975
  • O'Reilly T, Teeuwisse WM, de Gans D, Koolstra K, Webb AG. In vivo 3D brain and extremity MRI at 50 mT using a permanent magnet Halbach array. Magn Reson Med. 2021 Jan;85(1):495-505. doi: 10.1002/mrm.28396. Epub 2020 Jul 5. PMID 32627235

Идентификаторы

NCT: NCT07037966 · NextMRI Brain Validation

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗