- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07785024
CEST for Prostate Biopsy
Advanced Metabolic MRI to Refine Targeted Prostate Biopsy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Prostate Imaging and Data Reporting System assessment categories positively correlate with an increased likelihood of detecting clinically significant prostate cancer (csPCa) at targeted biopsy1. A PI-RADS assessment category 3 (intermediate, clinically significant cancer likelihood equivocal) lesion is often not csPCa. Studies evaluating the likelihood of csPCa cancer at targeted biopsy of PI-RADS category 3 lesions have reported variable rates of PCa diagnosis, ranging from 5-30%, with the majority of studies showing a relatively low likelihood of eventual csPCa diagnosis2-4. Management of PI-RADS category 3 lesion is variable, ranging from immediate biopsy to surveillance5,6. Given the disparity in management patterns for PI-RADS category 3 lesions and a small but not insignificant proportion of these lesions harboring csPCa, better classification of category 3 lesion is an unmet need. Previous studies in these patients have shown a correlation of csPCa with older patient age, smaller prostate volumes, higher prostate-specific antigen density (PSAD), and increased clinical stage7-11.
In this study, we will investigate the ability of magnetization transfer (MT) and chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI), without the use of any injected contrast agent, in conjunction with multiparametric magnetic resonance imaging (mpMRI) to aid in the detection of cancer, risk stratification and to decide whether a targeted prostate biopsy is justified. In this study, we propose to use the following ST-MRI techniques:
- Chemical Exchange Saturation Transfer (CEST) to probe changes in tumour metabolism.
- Magnetization Transfer (MT) to evaluate tumour environment microstructure.
Up to five healthy volunteers will be recruited for ST-MRI testing and estimation of test/re-test reproducibility. Testing of MR imaging protocols on healthy volunteers (without contrast agent) is required for optimization of sequence parameters including: higher signal intensity, higher contrast between tissue types, decreased scan time, and reduced image artifacts. There will be up to three MRI scans per healthy volunteer. MRI contrast agent will not be injected.
Patient recruitment will be performed at the Odette Cancer Centre. There will be one MRI scan per patient. All patients will undergo ST-MRI scans at Sunnybrook. ST-MRI parameter images including MTR, AREX, and quantitative MT model parameters, in addition to quantitative magnetization relaxation images will be used to identify areas of prostate with altered image contrast. Other quantitative and semiquantitative features will also be evaluated from the images. We hypothesize that ST-MRI will identify cancer suspicious areas that overlap with those identified by mpMRI and potentially additional areas.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Greg J Stanisz, PhD
- Número de teléfono: 416-480-5725
- Correo electrónico: greg.stanisz@utoronto.ca
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
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Investigador principal:
- Greg J Stanisz, PhD
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Investigador principal:
- Christopher Lim, MD
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Investigador principal:
- Danny Vesprini, MSc, MD
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Investigador principal:
- Stanley K Liu, MD, PhD
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- PI-RADS category 3 prostate cancer with upcoming targeted biopsy
Exclusion Criteria:
- Contraindications to MRI
- Prior radiotherapy
- Prior chemotherapy
- Prior prostate biopsy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Diagnostic Test: Saturation Transfer (ST)-MRI
Non-contrast magnetic resonance imaging "Saturation Transfer" scans consisting of magnetization transfer (MT) and chemical exchange saturation transfer (CEST)
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Saturation transfer MRI (chemical exchange saturation transfer and magnetization transfer) used to identify two additional biopsy locations in addition to those identified by conventional MRI.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Aiding the detection of prostate cancer
Periodo de tiempo: 1 year
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To determine whether MT/CEST MRI can aid in the detection of prostate cancer.
The histopathological detection of cancer in biopsy cores will serve as a measure of outcome to which the MT/CEST MRI parameter and relaxation images will be compared.
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Aiding risk stratification and the decision whether targeted prostate biopsy is justified
Periodo de tiempo: 1 year
|
To determine whether MT/CEST MRI can aid multiparametric MRI (mpMRI) in risk stratification and to decide whether targeted prostate biopsy is justified.
The presence of cancer detected histopathologically in biopsy locations suggested by MT/CEST MRI, but not chosen for biopsy by convention mpMRI will serve as a measure of outcome.
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1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Greg J Stanisz, PhD, Sunnybrook Research Institute
- Investigador principal: Christopher Lim, MD, Sunnybrook Health Sciences Centre
- Investigador principal: Danny Vesprini, MSc, MD, Sunnybrook Health Sciences Centre
- Investigador principal: Stanley K Liu, MD, PhD, Sunnybrook Health Sciences Centre
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Otros números de identificación del estudio
- 7378 (CTEP)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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