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Идёт набор NCT07031336

Photon-counting CT in Chest Imaging

Без фазы С лечением COPD (Chronic Obstructive Pulmonary Disease)

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: Photon-counting CT, Energy-integrating CT.
Кому может быть актуально
Состояния в реестре: COPD (Chronic Obstructive Pulmonary Disease). Базовые параметры: Без ограничений · 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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Официальное название

Photon-counting CT Post-processing Protocols for Robust Quantifications in Chest CT Scans

Обзор

Purpose and objective: This project aims to evaluate photon-counting computed tomography (PCCT) quantitative accuracy using COPDGene subjects. The goal is to establish acquisition protocols for PCCT scans with proper post-processing (e.g., reconstruction parameters and harmonization techniques) that enable reproducible measurements of emphysema metrics (e.g., Perc15, LAA-950, HU accuracy) and airways (Pi10, WA%) in the lungs. Study activities and population group: The study will recruit subjects from a current study at Duke (COPDGene Phase 4, Pro00113442). Here are the aims: * The research team will request consent from participants to acquire PCCT scans at their Phase 4 COPDGene visit. Scans will be performed using a PCCT-specific protocol. * Reconstruct the PCCT images with multiple post-acquisition parameter settings. Apply harmonization techniques that are recently developed by the investigators of this study. Data analysis: * Identify the reconstruction and harmonization conditions that enable reproducible measurements of emphysema metrics (perc15, LAA-950, HU accuracy) and airways (Pi10, WA%), when compared to the counterpart EICT scans. * Demonstrate the non-inferiority and potentially improved capabilities of PCCT scans in cross-sectional and longitudinal studies. Risk/safety issues: The participants are asked to get an additional CT scan with a PCCT scanner at their COPDGene Phase 4 visit. This additional CT scan will be done using an inspiratory chest protocol with a total of 3 mGy (\~1.5 mSv) radiation dose. This is roughly equivalent of 6 month of background radiation. Women who are pregnant will not have a chest CT scan done until they are confirmed to be not pregnant.

Вмешательства

  • Устройство Photon-counting CT
    The participants will receive a photon-counting CT scan as part of this protocol.
  • Устройство Energy-integrating CT
    The participants will receive an energy-integrating CT scan as part of the main study (NCT00608764).

Первичные конечные точки

  • Quantitative reproducibility as measured by consistency of Perc15 (15th Percentile of lung CT histogram in Hounsfield Unit) [Срок оценки: Day of Study Visit, approximately 30 minutes]
  • Quantitative reproducibility as measured by consistency of LAA-950 (Percentage of CT lung voxels below -950 Hounsfield Units) [Срок оценки: Day of Study Visit, approximately 30 minutes]
  • Quantitative reproducibility as measured by consistency of WA% (proportion of the airway wall area to the total airway area) [Срок оценки: Day of Study Visit, approximately 30 minutes]
  • Quantitative reproducibility as measured by consistency of Pi10 (square root of airway wall area for a hypothetical airway with a 10 mm lumen perimeter) [Срок оценки: Day of Study Visit, approximately 30 minutes]

Критерии участия

Критерии включения

  • This study recruit from the Duke-COPDGene Phase 4 study. All participants from this cohort is eligible and they will be included if they consent.

Критерии исключения

  • This study recruit from the Duke-COPDGene Phase 4 study. All participants from this cohort is eligible and they will be included if they consent.

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
Другое

Центры проведения

США · 1 центр
  • Duke University Hospital — Durham

Идентификаторы

NCT: NCT07031336 · PRO00117084

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗