- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01878058
Identifying Prostate Brachytherapy Seeds Using MRI
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- University Health Network, The Princess Margaret
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: MRI Scan
Patients will receive an extra MRI scan in addition to their routine scan.
|
Patient will receive an additional MRI scan in addition to their standard of care imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce registration errors
Time Frame: 6 months
|
6 months
|
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
|
6 months
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the differences in MR seed identification using the MR pulse sequence vs. CT images.
Time Frame: 6 months
|
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.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the prostate dosimetry (V100 and D90) in prostate low dose rate therapy using MR alone with CT/MR fusion.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Saibishkumar Elantholiparameswaran, MD, University Health Network, The Princess Margaret
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 12-5302-CE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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