Identifying Prostate Brachytherapy Seeds Using MRI

Prostate Cancer Patients Who Have Brachytherapy Seed Implant Clinical Trial

Official title:

Identifying Prostate Brachytherapy Seeds Using MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878058
• Other study ID #: UHN REB 12-5302-CE
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: October 31, 2016
• Start date: October 2012
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Review Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer Patients Who Have Brachytherapy Seed Implant
• Prostatic Neoplasms

Intervention

Other:
• MRI Scan
Patient will receive an additional MRI scan in addition to their standard of care imaging

Locations

Country	Name	City	State
Canada	University Health Network, The Princess Margaret	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the prostate dosimetry (V100 and D90) in prostate low dose rate therapy using MR alone with CT/MR fusion.		6 months	No
Primary	Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce registration errors		6 months	No
Primary	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	No
Primary	Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will eliminate the CT scan of the patient.		6 months	No
Secondary	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.	6 months	No