US-CT Fusion for Post Implant Dosimetry

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Juanita Crook，British Columbia Cancer Agency

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

November 3, 2017

Estimated Primary Completion Date

February 28, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Comparison of prostate dosimetry assessed by US-CT fusion with respect to the standard MR-CT fusion[ Time Frame: 1 month ]

Dosimetry will be calculated using 2 different imaging modalities (US vs MRI) and compared

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Comparison of prostate volume assessed by 2 different imaging modalities[ Time Frame: 1 month ]
Assessment of prostate volume as contoured on US vs MRI post implant

Descriptive Information

Brief Title ^ICMJE

US-CT Fusion for Post Implant Dosimetry

Official Title ^ICMJE

Comparison Between Postoperative Ultrasound-CT Fusion With MRI-CT Fusion for Postimplant Dosimetry for Prostate LDR Permanent Seed Brachytherapy

Brief Summary

Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, MR-CT fusion is preferred. This is not always available due to financial restrictions. This study explores the possibility of post implant US-CT fusion to improve contouring accuracy and potentially replace the use of MR-CT fusion.

Detailed Description

25 participants undergoing permanent seed prostate brachytherapy will be approached to undergo collection of prostate US images at the completion of their procedure. This will add approximately 5 minutes to the duration of their brachytherapy procedure. The US study will not entail any discomfort or risk to participants as they are still under anesthesia for the implant procedure. The institution standard of care for quality assurance will be complied with, obtaining a CT and MRI of the prostate at 30 days after the procedure. These will be co-registered and analyzed in the normal fashion. In addition, the post implant US images will also be co-registered with the CT and the resulting dosimetric parameters compared.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Diagnostic Test: transrectal ultrasound
Use of US for post implant quality assessment

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2018

Estimated Primary Completion Date

February 28, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - localized prostate cancer suitable for permanent seed implant brachytherapy as either monotherapy or as a boost Exclusion Criteria: - Unable to undergo MRI

Sex/Gender

Sexes Eligible for Study:

Male

Ages

40 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Juanita Crook，British Columbia Cancer Agency

Study Sponsor ^ICMJE

British Columbia Cancer Agency

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair: Francois Bachand, MD BC Cancer

PRS Account

British Columbia Cancer Agency

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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