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Identifying Prostate Brachytherapy Seeds Using MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01878058
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Patients Who Have Brachytherapy Seed Implant Other: MRI Scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identifying Prostate Brachytherapy Seeds Using MRI
Study Start Date : October 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MRI Scan
Patients will receive an extra MRI scan in addition to their routine scan.
Other: MRI Scan
Patient will receive an additional MRI scan in addition to their standard of care imaging




Primary Outcome Measures :
  1. Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce registration errors [ Time Frame: 6 months ]
  2. 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 ]
  3. 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 Measures :
  1. 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.


Other Outcome Measures:
  1. Compare the prostate dosimetry (V100 and D90) in prostate low dose rate therapy using MR alone with CT/MR fusion. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878058


Locations
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Canada, Ontario
University Health Network, The Princess Margaret
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
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Principal Investigator: Saibishkumar Elantholiparameswaran, MD University Health Network, The Princess Margaret
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01878058    
Other Study ID Numbers: UHN REB 12-5302-CE
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by University Health Network, Toronto:
Prostate cancer
Brachytherapy
Seed implant
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases