- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05176860
Оценка новой конусно-лучевой компьютерной томографии для контроля и адаптации прецизионной лучевой терапии
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
В этом исследовании основное внимание уделяется потенциальным преимуществам высокоэффективной системы визуализации с коническим лучом КТ (КЛКТ) для повышения точности проведения лучевой терапии. КЛКТ в настоящее время используется во время лучевой терапии, чтобы привести пациента в соответствие с его первоначальным планом лечения, чтобы повысить точность доставки излучения. Современная технология визуализации КЛКТ требует около минуты для получения изображения. Чтобы получить изображения достаточного качества для точного наведения, пациенту может потребоваться выполнить несколько маневров с задержкой дыхания, чтобы «заморозить» движение опухолей, которые движутся вместе с дыхательным циклом (например, опухоли легких, печени и молочной железы). Новый высокопроизводительный КЛКТ может получить изображение примерно за 6 секунд, что потенциально позволяет получать изображения с одной задержкой дыхания. Усовершенствованные алгоритмы компенсации движения, используемые при реконструкции изображений, могут позволить получать изображения хорошего качества, даже когда пациент не задерживает дыхание.
Методология настройки лечения субъекта, моделирования КТ, планирования лечения, визуального контроля и проведения лечения будет определяться лечащей группой субъекта и не указывается в этом исследовании. Включение в исследование может произойти после начала лечения, но должно быть до пятой фракции.
После получения информированного согласия на участие в этом исследовании будет назначена высокоэффективная КЛКТ-визуализация непосредственно до или после одной из первых пяти запланированных фракций лучевой терапии субъекта. Будут получены два исследовательских изображения CBCT, одно с задержкой дыхания, другое со свободным дыханием.
С минимальным нарушением для участвующих пациентов это исследование позволит сравнить (i) план лечения пациента с веерной лучевой КТ и (ii) обычную КЛКТ, полученную в существующем лечебном отделении, с (iii) высокоэффективной КЛКТ. Таким образом, качество изображения высокопроизводительных данных изображения КЛКТ будет сравниваться как со стандартом наилучшего случая (веерный луч), так и со статусом-кво для изображений на кушетке, чтобы выделить и определить улучшения.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Nova Scotia
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Halifax, Nova Scotia, Канада, B3H 2E2
- Nova Scotia Health (QEII)
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Описание
Критерии включения:
- Субъекту назначено лечение на одной из пяти платформ TrueBeam в центре NS Health QE2.
- Субъект получает лучевую терапию с использованием техники задержки дыхания (например, рак легких, печени и левой молочной железы).
Критерий исключения:
- Пациентка беременна или планирует беременность в период лечения.
- Пациент не желает давать согласие на участие в исследовании или для которого информированное согласие невозможно.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Высокопроизводительная КЛКТ-визуализация
Приобретены два дополнительных набора изображений для исследования.
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Каждому субъекту будут получены два исследовательских КЛКТ-изображения.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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CBCT Image Quality - Artifact Index
Временное ограничение: 1 day
|
Artifact Index (AI) is a measurement of the strength of imaging artifact and the degree to which is affects visibility of anatomical structures in the vicinity of the artifact. Artifacts can be produced in CT and CBCT images by a number of factors, such as metal implants, gas, or breathing motion. AI = sqrt((STD_VOI)^2 - (STD_background)^2), where STD_VOI is the standard deviation of the image Hounsfield Units in a region of interest at the location of an artifact, and STD_background is the standard deviation of the Hounsfield Unit values in the background (i.e. in similar tissue but away from the artifact. A lower AI value indicates that the artifact has a lower impact on image quality. Artifacts were identified in all study participants. The median AI across the study population is presented for four imaging modalities. |
1 day
|
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CBCT Image Quality - Image Nonuniformity
Временное ограничение: 1 day
|
Nonuniformity (NU) is a measure of the variation of CT image intensity in uniform tissue. NU = (HU_max - HU_min)/(HU_max + HU_min), where HU_max and HU_min are the maximum and minimum Hounsfield Unit values among multiple locations sampled within regions of uniform tissue that were relevant to the anatomy of interest (e.g., a uniform region of breast tissue for patients undergoing breast treatments). A lower NU represents greater uniformity of CT image intensity within a region of interest. Median NU across the study population is presented for four imaging modalities. |
1 day
|
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CBCT Image Quality - Contrast
Временное ограничение: 1 week
|
Contrast represents the ability to distinguish between two different regions in a CT image (e.g. to distinguish between two adjacent organs). Contrast = |HU1 - HU2| where HU1 and HU2 are the mean HU values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments). Higher contrast values indicate that it is easier to distinguish between regions (anatomical structures) in a CT image. Median contrast across the study population is presented for four imaging modalities. |
1 week
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CBCT Image Quality - Contrast to Noise Ratio
Временное ограничение: 1 week
|
Contrast to Noise Ratio (CNR) measures the ability to distinguish an object or lesion from its background. CNR = |HU1 - HU2|/[0.5 (STD1 + STD2)] where HU1 and HU2 are the mean Hounsfield Unit values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments), and STD1 and STD2 are the standard deviations of the HU values in those same ROIs. A higher CNR makes it easier to distinguish an object from its background. CNR analysis was limited to images with similar imaging dose. Median CNR across all study participants treated for lung cancer are presented for three CBCT modalities. |
1 week
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CBCT Image Quality - HU Similarity to CT Simulation
Временное ограничение: 1 week
|
The intensity of a pixel in a CT image is a function of its Hounsfield Unit (HU) value. HU is also directly related to the underlying electron density, which means that the pixel value of a CT image can be used directly in the calculation of dose for a prescribed radiation treatment plan. CT simulation scanners produce images with high HU accuracy and are regularly used for radiation treatment planning. Here, we present the difference in HU between CT simulation images and different CBCT images. ΔHU = HU_CBCT - HU_CTSim, where HU_CBCT and HU_CTSim are mean values among HU averages at 4 reference points in a CBCT image and the corresponding CT simulation image, respectively. The lower the ΔHU, the greater the HU accuracy of the CBCT image, and the greater the likelihood that CBCT imaging can be used for radiation treatment planning. Median ΔHU across the study population are presented for three different tissue types for three CBCT imaging modalities. |
1 week
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Dosimetry Calculations - Gamma Pass Rate
Временное ограничение: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
The overall difference between calculated radiation distributions was evaluated using three different gamma pass criteria: 3% dose difference / 3 mm distance to agreement, 2%/2mm, and 1%/1mm.
The gamma pass rate is expressed as a percentage of data points that meet the pass criteria.
A gamma pass rate of > 95% is typically considered acceptable for 3%/3mm.
As the gamma pass criteria become stricter, the pass rates decrease.
Gamma pass rates were calculated to compare the CT simulation-based dose calculation and the high performance CBCT-based dose calculation.
Gamma pass rates were also calculated to compare the CT simulation-based dose calculation and the conventional CBCT-based dose calculation.
The median gamma pass rates across the entire study population are presented.
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1 day
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Dosimetry Calculations - Target DVH Volume Metrics
Временное ограничение: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions.
Individual DVH metrics, such as V90(%) (the percentage of the structure volume receiving 90% of the prescribed radiation dose) were extracted for individual target structures from their DVH.
The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median target DVH metric differences across the study population are presented.
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1 day
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Dosimetry Calculations - Target DVH Dose Metrics
Временное ограничение: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions.
Individual DVH dose metrics, such as D95(%) (the minimum dose covering 95% of the structure, expressed as a % of the prescription dose) were extracted for individual target structures from their DVH.
The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median target DVH metric differences across the study population are presented.
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1 day
|
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Dosimetry Calculations - Breast OAR DVH Metrics
Временное ограничение: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions.
The key organs at risk for patients being treated for breast cancer are the heart, ipsilateral lung, and contralateral breast.
The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median differences in OAR D2%(%) across study participants treated for breast cancer are presented.
|
1 day
|
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Dosimetry Calculations - Lung OAR DVH Metrics
Временное ограничение: 1 day
|
Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions.
The key organs at risk for patients being treated for lung cancer are the heart, esophagus and spinal cord.
The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median differences in OAR D2%(%) across study participants treated for lung cancer are presented.
|
1 day
|
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Dosimetry Calculations - Abdomen OAR DVH Metrics
Временное ограничение: 1 day
|
Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions.
The key organs at risk for patients being treated for abdominal cancer are the heart, bowel and kidneys.
The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median differences in OAR D2%(%) across study participants treated for abdominal cancer are presented.
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1 day
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Patient Experience - General Ease of Breath Hold
Временное ограничение: 1 Day
|
Study participants were asked to respond to the statement, "I find it easy to hold my breath", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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Patient Experience - Ease of Breath Hold on TrueBeam
Временное ограничение: 1 Day
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Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds that were needed for imaging on the TrueBeam radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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Patient Experience - Ease of Breath Hold on Ethos
Временное ограничение: 1 Day
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Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds needed for imaging on the Ethos radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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Patient Experience - Relative Ease of Breath Hold Between Machines
Временное ограничение: 1 Day
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Study participants were asked to respond to the statement, "It was easier for me to perform the breath holds needed for imaging on one radiation machine compared to the other", on a 5-point scale, where 1 represents "TrueBeam much easier", 3 represents "Both machines equally easy", and 5 represents "Ethos much easier".
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1 Day
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Patient Experience - Overall TrueBeam Experience
Временное ограничение: 1 Day
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Study participants were asked to respond to the statement, "My overall experience during imaging on the TrueBeam was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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Patient Experience - Overall Ethos Experience
Временное ограничение: 1 Day
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Study participants were asked to respond to the statement, "My overall experience during imaging on the Ethos platform was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Новообразования пищеварительной системы
- Заболевания пищеварительной системы
- Легочные заболевания
- Заболевания печени
- Новообразования дыхательных путей
- Грудные новообразования
- Кожные заболевания
- Заболевания груди
- Заболевания кожи и соединительной ткани
- Новообразования легких
- Новообразования молочной железы
- Новообразования печени
Другие идентификационные номера исследования
- VAR-2021-12
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .