NCT01878058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

October 23, 2012

Last Update Submit

October 31, 2016

Conditions

Prostate Cancer Patients Who Have Brachytherapy Seed Implant

Keywords

Prostate cancerBrachytherapySeed implant

Outcome Measures

Primary Outcomes (3)

  • Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce registration errors

    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

    6 months

  • Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will eliminate the CT scan of the patient.

    6 months

Secondary Outcomes (1)

  • Compare the differences in MR seed identification using the MR pulse sequence vs. CT images.

    6 months

Other Outcomes (1)

  • Compare the prostate dosimetry (V100 and D90) in prostate low dose rate therapy using MR alone with CT/MR fusion.

    6 months

Study Arms (1)

MRI Scan

OTHER

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

Other: MRI Scan

Interventions

MRI ScanOTHER

Patient will receive an additional MRI scan in addition to their standard of care imaging

MRI Scan

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication for Pelvic body MRI
  • Patient not willing/consenting for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, The Princess Margaret

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Saibishkumar Elantholiparameswaran, MD

    University Health Network, The Princess Margaret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2012

First Posted

June 14, 2013

Study Start

October 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

CA(1)