Completado

IGPC-2Multi-modality Prostate Cancer Image Guided Interventions

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Imaging Panel

Otro
Quiénes están siendo reclutados

Enfermedades Urogenitales+6

+ Enfermedades Genitales

+ Enfermedades Genitales Masculinas

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio Diagnóstico

Intervencional
Inicio del estudio: febrero de 2012
Ver detalles del protocolo

Resumen

Patrocinador PrincipalLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 12 de febrero de 2012

Fecha en la que se inscribió al primer participante.

This study was built on our first study (IGPC-1, REB number 15551) which acquired multi-modality imaging in 36 patients undergoing radical prostatectomy. We successfully demonstrated the ability to accurately co-register pre-operative multi-modality images (MRI: T1, T2, Diffusion Weighed (DW), Dynamic Contrast enhanced (DCE); Dynamic Contrast Enhanced CT, 3D Ultrasound with post-operative whole mount pathology specimens. We have developed a platform for the segmentation of prostate cancer on the whole mount pathology specimens and are in the process of analyzing the data to develop a hybrid imaging map (HIM) of prostate cancer distribution (location and grade) based on the correlation of the pre-operative imaging signals and the post-operative pathology (citation provided below). The HIM will need subsequent validation in a separate cohort of radical prostatectomy patients and evaluated as to its ability to be incorporated as a targeting tool for prostate interventions such as prostate biopsy and this is the purpose of this follow-up study. On the IGPC-2 study, pre-operative imaging panels were successfully obtained in 24 patients accrued to cohort 1. The protocol was then amended to include \[18-F\]-DCFPyl instead of \[18F\]-FCH. \[18-F\]-DCFPyl was a newer PET probe that may possess superior performance because it is directed against prostate specific membrane antigen (PSMA), a protein commonly expressed on prostate cancer cells. Imaging-pathology correlations in the first 6 patients imaged with \[18-F\]-DCFPyl were compared to the correlations obtained with \[18F\]-FCH imaging in the first 24 patients. IGPC-2 Cohort 1 (Radical Prostatectomy) was expanded to provide an additional 20 men imaged with \[18-F\]-DCFPyl as part of the imaging panel. The goal was to acquire 24 complete imaging datasets with \[18-F\]-DCFPyl as the PET imaging agent to enable us to draw comparisons with the 24 \[18F\]-FCH imaging data sets acquired.

Título OficialMulti-modality Prostate Cancer Image Guided Interventions
Patrocinador PrincipalLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 52 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio Diagnóstico

Los estudios diagnósticos se centran en mejorar como se detecta o confirma una enfermedad. Prueban nuevas herramientas o técnicas que podrían ofrecer diagnósticos más rápidos o precisos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Hombre

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades UrogenitalesEnfermedades GenitalesEnfermedades Genitales MasculinasNeoplasias Genitales MasculinasNeoplasiasNeoplasias por SitioNeoplasias prostáticasEnfermedades ProstáticasNeoplasias Urogenitales

Criterios

Inclusion Criteria: * Provision of informed consent for this study * Male, aged 18 years or older * Pathologically confirmed prostate cancer on previous biopsy * Suitable for and consenting to Radical Prostatectomy for treatment, or repeat biopsy as standard of care Exclusion Criteria: * Prior therapy for prostate cancer (including hormone therapy), with the exception of radiation therapy for Cohort 2 only * Use of 5-alpha reductase inhibitors, i.e. finasteride (Proscar) or dutasteride (Avodart) within 6 months of study start. Patients undergoing a 6-month washout period prior to study start will be eligible. * Inability to comply with the pre-operative imaging panel * Patients scheduled for radical prostatectomy with prostate size exceeding dimensions for whole mount pathology slides * Allergy to contrast agents to be used as part of the imaging panel * Sickle cell disease or other anemias * Insufficient renal function (eGFR \< 60 mL/min/1.73 m2) * Residual bladder volume \> 150 cc (determined by post-void ultrasound) * Hip prosthesis, vascular grafting that is MRI incompatible or sources of artifact within the pelvis * Contraindication to MRI * pacemaker or other electronic implants * known metal in the orbit * cerebral aneurysm clips

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Patients who provided written informed consent and found to be eligible for study were asked to complete Positron Emission Tomography (PET) + Dynamic CT imaging, PET/MRI (with endorectal coil) and 3D-Transrectal ultrasound prior to standard of care radical prostatectomy.

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

London Health Sciences Centre

London, CanadaAbrir London Health Sciences Centre en Google Maps
Completado1 Centros de Estudio
IGPC-2 | Multi-modality Prostate Cancer Image Guided Interventions | PatLynk