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Identifying Prostate Brachytherapy Seeds Using MRI

Primary Purpose

Prostate Cancer Patients Who Have Brachytherapy Seed Implant

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI Scan
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer Patients Who Have Brachytherapy Seed Implant focused on measuring Prostate cancer, Brachytherapy, Seed implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 18 years old
  2. Histologic diagnosis of adenocarcinoma of the prostate
  3. No contraindications for Pelvic body MRI
  4. Patients undergoing LDR brachytherapy at PMH and scheduled for post implant analysis with CT-MR (standard at PMH)
  5. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  1. Contraindication for Pelvic body MRI
  2. Patient not willing/consenting for this study

Sites / Locations

  • University Health Network, The Princess Margaret

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRI Scan

Arm Description

Patients will receive an extra MRI scan in addition to their routine scan.

Outcomes

Primary Outcome Measures

Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce registration errors
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce planning time for the post-implant plan
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will eliminate the CT scan of the patient.

Secondary Outcome Measures

Compare the differences in MR seed identification using the MR pulse sequence vs. CT images.
Our goal is to perfectly match these two modalities with acceptance test of 97%. This technique would be beneficial for LDR (Low Dose Rate) Brachytherapy without need to fuse the CT and MR images and eliminate any image registration uncertainly.

Full Information

First Posted
October 23, 2012
Last Updated
October 31, 2016
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01878058
Brief Title
Identifying Prostate Brachytherapy Seeds Using MRI
Official Title
Identifying Prostate Brachytherapy Seeds Using MRI
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will look at the feasibility of using a type of Magnetic Resonance Imaging called Susceptibility Weighted Imaging (SWI) to detect your implanted radioactive seeds. Researchers hope that using SWI will eliminate the need to use CT imaging to detect your implanted radioactive seeds. This study will also see if the MRI seed detection is as effective as current standard practice of seed detection (routine MRI and CT imaging). This technique would be beneficial for brachytherapy without the need to fuse the MRI and CT images, as is done currently.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Patients Who Have Brachytherapy Seed Implant
Keywords
Prostate cancer, Brachytherapy, Seed implant

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI Scan
Arm Type
Other
Arm Description
Patients will receive an extra MRI scan in addition to their routine scan.
Intervention Type
Other
Intervention Name(s)
MRI Scan
Intervention Description
Patient will receive an additional MRI scan in addition to their standard of care imaging
Primary Outcome Measure Information:
Title
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce registration errors
Time Frame
6 months
Title
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce planning time for the post-implant plan
Time Frame
6 months
Title
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will eliminate the CT scan of the patient.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Compare the differences in MR seed identification using the MR pulse sequence vs. CT images.
Description
Our goal is to perfectly match these two modalities with acceptance test of 97%. This technique would be beneficial for LDR (Low Dose Rate) Brachytherapy without need to fuse the CT and MR images and eliminate any image registration uncertainly.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Compare the prostate dosimetry (V100 and D90) in prostate low dose rate therapy using MR alone with CT/MR fusion.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old Histologic diagnosis of adenocarcinoma of the prostate No contraindications for Pelvic body MRI Patients undergoing LDR brachytherapy at PMH and scheduled for post implant analysis with CT-MR (standard at PMH) Ability to provide written informed consent to participate in the study Exclusion Criteria: Contraindication for Pelvic body MRI Patient not willing/consenting for this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saibishkumar Elantholiparameswaran, MD
Organizational Affiliation
University Health Network, The Princess Margaret
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, The Princess Margaret
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Identifying Prostate Brachytherapy Seeds Using MRI

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