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Набор скоро начнётся NCT07533981

¹²⁹Xe(XENON) MRI Program

Без фазы С лечением Healthy Volunteers - Male and Female

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: Hyperpolarized Xenon MRI.
Кому может быть актуально
Состояния в реестре: Healthy Volunteers - Male and Female. Базовые параметры: 18 лет — 85 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
Канада
Следующий шаг
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Официальное название

HARDWARE AND SOFTWARE DEVELOPMENT FOR PULMONARY MAGNETIC RESONANCE IMAGING USING INHALED INERT HYPERPOLARIZED ¹²⁹XENON GAS

Обзор

Healthy volunteers aged 18 to 85 will undergo hyperpolarized Xenon-129 (¹²⁹Xe) MRI and pulmonary function testing. The study aims to develop evaluation tools for ventilation defect percent (VDP), signal-to-noise and contrast-to-noise ratios (SNR/CNR) of ¹²⁹Xe dissolved-phase images, and spectroscopy-based analysis.

Подробное описание

Briefly, during a one hour visit, subjects will provide written informed consent and then undergo:

1. brief medical history and vital signs, 2. full pulmonary function tests, 3. proton MRI, 4. spin-density, diffusion weighted, and/or dissolved phase 129-Xe MRI, Full pulmonary function tests including spirometry and FeNO test according to American Thoracic Society (ATS) guidelines.

Subjects will be placed in the 3T Magnetic Resonance (MR) scanner with one 129-Xe chest coil fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient radiofrequency (RF) coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation.

Вмешательства

  • Устройство Hyperpolarized Xenon MRI
    Hyperpolarized noble gas imaging using Xenon-129 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 129Xe gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical

Первичные конечные точки

  • Signal-to-noise ratio (SNR) [Срок оценки: 5 years]
  • Contrast-to-noise ratio (CNR) [Срок оценки: 5 years]
  • Image spatial resolution [Срок оценки: 5 years]
  • Scan duration (minutes) [Срок оценки: 5 years]
Вторичные конечные точки (1)
  • Ventilation Defect Percent (VDP) of the lung [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature.
  • Provision of written, informed consent prior to any study specific procedures.
  • Males and females aged 18 to 85 years.
  • Participant must be able to perform a breath-hold for 16s.
  • Participant has a BMI between 18 and 40
  • Participant must be able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater)
  • Participants are judged to be in stable health on the basis of medical history

Критерии исключения

  • Patient has an MR incompatible implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
  • In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia.
  • Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.
  • Participant is unable to perform spirometry maneuvers.
  • Participant is unable to perform MRI and CT breath-hold maneuvers.
  • Participant has a history of chronic or acute respiratory disease
  • FEV1 <70%
  • Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension (≥160 over ≥100)
  • Participant has a daytime room air oxygen saturation ≤ 92% ± 2% while supine

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • St Joseph's Healthcare London — London

Идентификаторы

NCT: NCT07533981 · SJHC0002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗