- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05380609
Accelerated Body Diffusion-Weighted MRI Using Artificial Intelligence (CeleScan-R)
Whole-body diffusion-weighted MRI (WBDWI) is a non-invasive tool used for staging and response evaluation in oncologic practice and is at the core of emerging response criteria in advanced prostate and breast cancers.
WBDWI is a sensitive tool that radiologists can use to review the extent of disease and is achieved using a series of sequential imaging stations from the head to the mid-thigh. WBDWI accounts for more than 50% of the acquisition time of conventional whole-body MRI studies with a 1-hour duration. Despite national and international guidance for using whole-body MRI, a recent UK survey indicated that only 27% of UK radiology departments were offering a whole-body MRI service with a lack of scanner availability cited by 50% of respondents as the main challenge to service delivery. In the context of the ever-increasing capacity pressures on MRI departments, reducing acquisition times would facilitate the wider adoption of clinical WBDWI, reduce costs, and improve the patient experience.
DWI is also embedded into consensus MRI protocols across almost all tumour types including primary prostate and breast cancers, metastatic liver disease, gynaecological cancers & GI cancers, where acquisition time savings could also be beneficial. The investigators have previously published accelerated DWI with deep learning based denoising filters (quickDWI), which can provide up to 50% reduction in whole-body MRI acquisition times. The goal of the deep-learning algorithm is to remove the noise in these subsampled images, producing an image with acceptable clinical quality.
The aim of this investigation is to extend this work by testing quickDWI within a larger retrospective data cohort, incorporating other cancers such as disease of the abdomen and pelvis, primary prostate cancer, liver metastases, and pancreatic cancer.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Surrey
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Sutton, Surrey, Reino Unido, SM2 5PT
- Department of Radiology, The Royal Marsden NHS Foundation Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Patients who have received one of the following MRI examinations (scan type shown in parentheses):
- Multiple Myeloma (whole-body)
- Metastatic Prostate Cancer (whole-body)
- Metastatic Breast Cancer (whole-body)
- Liver Metastases (stacked abdomen/pelvis)
- Pancreatic Cancer (stacked abdomen/pelvis)
- Gynaecological Cancers (stacked abdomen/pelvis)
- Gastrointestinal Cancers (stacked abdomen/pelvis)
- Primary Prostate Cancers (multiparametric Prostate exam)
- Patients who have received one of the above-mentioned scan types using a modified clinical multi-direction diffusion-weighted (MDDW) MRI protocol as part of standard of care.
Exclusion Criteria:
- No exclusion criteria as this is a retrospective data study only.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Qualitative image comparison
Periodo de tiempo: Throughout study completion, 3 years
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The primary endpoint is the qualitative comparison of radiological image quality on a 5-point Likert scale (5 being the best) for quickDWI images and conventional clinical images.
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Throughout study completion, 3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Qualitative contrast-to-noise-ratio comparison
Periodo de tiempo: Throughout study completion, 3 years
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Qualitative radiological contrast-to-noise-ratio (CNR) on a 5-point Likert scale (5 being the best), for quickDWI images and conventional clinical images.
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Throughout study completion, 3 years
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Qualitative artefact comparison
Periodo de tiempo: Throughout study completion, 3 years
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Qualitative scoring for presence of image artefacts on a 5-point Likert scale (5 being the best), for quickDWI images and conventional clinical images.
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Throughout study completion, 3 years
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Inter-observer comparison
Periodo de tiempo: Throughout study completion, 3 years
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Krippendorff's alpha coefficient for inter-observer agreement of image quality, CNR and image artefacts.
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Throughout study completion, 3 years
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Repeatability comparison
Periodo de tiempo: Throughout study completion, 3 years
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The coefficient of repeatability of median ADC measurements within regions-of-interest (ROIs) defined in the same anatomical areas on both quickDWI and standard clinical imaging.
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Throughout study completion, 3 years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CCR5653
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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