The Spiral MRI Study

Официальное название

MRI Technology for Greater Efficiency and Improved Value

Обзор

The goal of this clinical trial is to find out if new Magnetic Resonance Imaging (MRI) computer software will: * help make scans and exams faster * reduce artifacts * make MRI easier to understand * allow technicians to focus more on the participant and less on the scanner Participants will complete one brain MRI imaging session, lasting about 60 minutes.

Подробное описание

The overall goal of this application is to design technologies that improve the value of MRI, and specifically mitigate many of the complications that negatively impact this value. The scope of MRI value is vast, but can be expressed by efficiency (high patient throughput and consistent image quality), accessibility (better scope of use and equity of availability), safety, and user experience for the patient, technologist, and interpreting physician.

Вмешательства

• Устройство Brain MRI
  90 participants will undergo a 60 minute SOC brain MRI followed by 15 minute spiral MRI
• Устройство Brain MRI - SOC and spiral
  6 participants will be scanned using 2 versions (SOC and spiral) pf 6 sequences (12 scans total).
• Устройство Brain MRI - spiral
  10 participants will be scanned with 3 sequences, 3 times (9 total scans per participants)
• Устройство Brain MRI - SOC and spiral
  10 participants will be scanned using 2 versions (SOC and spiral) of 6 sequences (12 scans total).
• Устройство Brain MRI - spiral
  10 participants will be scanned with 3 spiral sequences to achieve desired signal to noise ratio (SNR).
• Устройство Brain MRI - spiral
  5 participants will be scanned with 2 pairs of 6 spiral sequences.

Первичные конечные точки

• Image quality - decreasing scan time [Срок оценки: 60 minutes]
• Image quality - tau [Срок оценки: 60 minutes]
• Image quality - consistent scan time [Срок оценки: 60 minutes]
• Signal to Noise Ratio (SNR) [Срок оценки: 60 minutes]
• Image quality - acoustic comfort [Срок оценки: 60 minutes]
• Acoustic noise [Срок оценки: 60 minutes]
• Difference in Image quality [Срок оценки: 60 minutes]

Критерии участия

Healthy Controls Inclusion Criteria:

• Adults at least 18 years
• Able to provide written informed consent on their own behalf

Brain MR Inclusion Criteria:

• Adults at least 18 years
• Able to provide written informed consent on their own behalf
• Scheduled for standard of care brain MRI

Exclusion Criteria (ALL):

• Unable or unwilling to provide informed consent
• Contraindication(s) to or inability to undergo MRI
• Currently pregnant
• Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed as long as the following criteria are met:
• participant has their own prescription for the medication
• informed consent process is conducted prior to the self-administration of the medication
• they come to the research visit with a driver

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Wisconsin - Madison — Madison

Идентификаторы

NCT: NCT07167953 · 2025-0948 · 1R01EB036009-01A1 · A539300 · SMPH/RADIOLOGY/RADIOLOGY · Protocol Version 6/2/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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