US-CT Fusion for Post Implant Dosimetry

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692104
• Other study ID #: H17-02634
• Status: Completed
• Start date: November 3, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2019
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• localized prostate cancer suitable for permanent seed implant brachytherapy as either monotherapy or as a boost

Exclusion Criteria:

• Unable to undergo MRI

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	BC Cancer	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of prostate dosimetry assessed by US-CT fusion with respect to the standard MR-CT fusion	Dosimetry will be calculated using 2 different imaging modalities (US vs MRI) and compared	1 month
Secondary	Comparison of prostate volume assessed by 2 different imaging modalities	Assessment of prostate volume as contoured on US vs MRI post implant	1 month