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US-CT Fusion for Post Implant Dosimetry

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ClinicalTrials.gov Identifier: NCT03692104
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Juanita Crook, British Columbia Cancer Agency

Study Description
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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.

Condition or disease Intervention/treatment
Prostate Cancer Diagnostic Test: transrectal ultrasound

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 Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between Postoperative Ultrasound-CT Fusion With MRI-CT Fusion for Postimplant Dosimetry for Prostate LDR Permanent Seed Brachytherapy
Actual Study Start Date : November 3, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: transrectal ultrasound
    Use of US for post implant quality assessment

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients undergoing prostate brachytherapy for localized prostate cancer.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to undergo MRI
Contacts and Locations
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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): NCT03692104


Locations
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Canada, British Columbia
BC Cancer
Kelowna, British Columbia, Canada, V1Y5L3
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
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Study Chair: Francois Bachand, MD BC Cancer
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Juanita Crook, Radiation Oncologist, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT03692104    
Other Study ID Numbers: H17-02634
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juanita Crook, British Columbia Cancer Agency:
prostate cancer
brachytherapy
Quality assurance
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases