4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Multi-modality Prostate Cancer Image Guided Interventions (IGPC-2)

Multi-modality Prostate Cancer Image Guided Interventions (IGPC-2)

Study Description
Brief Summary:
This is a non-randomized, prospective trial of men who are scheduled for radical prostatectomy for treatment of prostate cancer, or repeat biopsy for localized prostate cancer as standard of care and who will undergo a series of pre-operative multi-modality imaging studies. Post intervention, hybrid imaging maps (HIM) will be generated and the predictions of the HIM (3D location, volume and grade of cancer) will be correlated with actual pathology results to gauge the performance of the HIM in both radical prostatectomy and biopsy settings.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Imaging Panel Not Applicable

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multi-modality Prostate Cancer Image Guided Interventions
Actual Study Start Date : February 12, 2012
Actual Primary Completion Date : January 9, 2018
Estimated Study Completion Date : January 9, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Imaging Panel
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.
 Other: Imaging Panel

Initial Protocol (REB approval date 08-Sept-2011)

Pre-operative Imaging Panel

  • [18F]-FCH PET + Dynamic CT
  • MRI of the pelvis with endorectal coil (T1, T2, DW, DCE, MRS)
  • 3D-Transrectal ultrasound
  • Optional PET/MRI (added with Protocol Amend 1, REB approval date 22-Aug-2012)
  • Optional Sodium (23Na) MRI (added with Protocol Amend 2, REB approval date 25-Feb-2013)

Protocol Amendment #3, REB approval date 20-Oct-2015:

Pre-operative Imaging Panel

  • [18-F]-DCFPyL PET+Dynamic CT
  • PET/MRI with endorectal coil
  • 3D-Transrectal Ultrasound
  • Optional Sodium (23Na) MRI
Outcome Measures
Primary Outcome Measures :
  1. Hybrid Imaging Map (HIM) Validation [ Time Frame: Within two years of study completion. ]
    We will determine if individualized hybrid imaging maps (HIMs) based on a pre-operative imaging panel accurately predicts the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery.


Other Outcome Measures:
  1. MRI Prostate Sodium Imaging Validation [ Time Frame: Within two years of study completion ]
    We will determine if sodium levels in the prostate based on a pre-operative sodium MRI accurately predicts the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male with a prostate
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Dr. Glenn Bauman, MD Lawson Health Research Institute
Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE February 12, 2012
Actual Primary Completion Date January 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019) 		Hybrid Imaging Map (HIM) Validation [ Time Frame: Within two years of study completion. ]
We will determine if individualized hybrid imaging maps (HIMs) based on a pre-operative imaging panel accurately predicts the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 3, 2019) 		MRI Prostate Sodium Imaging Validation [ Time Frame: Within two years of study completion ]
We will determine if sodium levels in the prostate based on a pre-operative sodium MRI accurately predicts the actual cancer distribution found in the whole mount prostatectomy specimens obtained from the surgery.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Multi-modality Prostate Cancer Image Guided Interventions
Official Title  ICMJE Multi-modality Prostate Cancer Image Guided Interventions
Brief Summary This is a non-randomized, prospective trial of men who are scheduled for radical prostatectomy for treatment of prostate cancer, or repeat biopsy for localized prostate cancer as standard of care and who will undergo a series of pre-operative multi-modality imaging studies. Post intervention, hybrid imaging maps (HIM) will be generated and the predictions of the HIM (3D location, volume and grade of cancer) will be correlated with actual pathology results to gauge the performance of the HIM in both radical prostatectomy and biopsy settings.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Other: Imaging Panel

Initial Protocol (REB approval date 08-Sept-2011)

Pre-operative Imaging Panel

  • [18F]-FCH PET + Dynamic CT
  • MRI of the pelvis with endorectal coil (T1, T2, DW, DCE, MRS)
  • 3D-Transrectal ultrasound
  • Optional PET/MRI (added with Protocol Amend 1, REB approval date 22-Aug-2012)
  • Optional Sodium (23Na) MRI (added with Protocol Amend 2, REB approval date 25-Feb-2013)

Protocol Amendment #3, REB approval date 20-Oct-2015:

Pre-operative Imaging Panel

  • [18-F]-DCFPyL PET+Dynamic CT
  • PET/MRI with endorectal coil
  • 3D-Transrectal Ultrasound
  • Optional Sodium (23Na) MRI
Study Arms  ICMJE Experimental: Imaging Panel
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.
Intervention: Other: Imaging Panel
Publications *
  • Ward A, Crukley C, McKenzie C, Montreuil J, Gibson E, Gomez JA, et al. Registration of in vivo prostate magnetic resonance images to digital histopathology images. MICCAI'10 Proceedings of the 2010 international conference on Prostate cancer imaging: computer-aided diagnosis, prognosis, and intervention; Bejing, China. Berlin: Springer-Verlag; 2010.
  • Yang DM, Li F, Bauman G, Chin J, Pautler S, Moussa M, Rachinsky I, Valliant J, Lee TY. Kinetic analysis of dominant intraprostatic lesion of prostate cancer using quantitative dynamic [(18)F]DCFPyL-PET: comparison to [(18)F]fluorocholine-PET. EJNMMI Res. 2021 Jan 4;11(1):2. doi: 10.1186/s13550-020-00735-w.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019) 		52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 9, 2020
Actual Primary Completion Date January 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Male with a prostate
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009174
Other Study ID Numbers  ICMJE 101038
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Fully anonymized study data such as de-identified images, digital pathology slides, prostate tissue slides and prostate cancer diagnosis information can be available for data analysis.
Access Criteria: Institutionally approved material sharing agreement.
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Dr. Glenn Bauman, MD Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯