Back to resultsApplication of Megavoltage Imaging to Reduce Artifact After Seed Implants
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
MVCT
Sponsored by
About this trial
This is an observational trial for Prostate Cancer focused on measuring Prostate, Cancer
Eligibility Criteria
Inclusion Criteria:
Male 50-80 years of age Eligible for interstitial brachytherapy implants
Exclusion Criteria:
-
Sites / Locations
- Markey Cancer Center
Arms of the Study
Arm 1
Arm Type
Arm Label
MVCT
Arm Description
Patients will receive an additional MVCT scan at their one month follow up visit.
Outcomes
Primary Outcome Measures
Change in prostate volume measured in cm^3
Change in prostate volume measured with trans-rectal ultrasound at baseline versus prostate volume measured with KVCT and MVCT.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01810627
Brief Title
Application of Megavoltage Imaging to Reduce Artifact After Seed Implants
Official Title
Application of Megavoltage Imaging to Reduce Artifact Following Interstitial Seed Implants for Prostate Adenocarcinoma
Study Type
Observational
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William St Clair
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure in patients treated with interstitial permanent seed implants for low and intermediate risk prostate cancer. All patients will received the same standard of care treatment but will receive an additinoal CT image of the prostate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Cancer
7. Study Design
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MVCT
Arm Description
Patients will receive an additional MVCT scan at their one month follow up visit.
Intervention Type
Radiation
Intervention Name(s)
MVCT
Intervention Description
Patients will receive an additional MVCT scan at their one month follow up visit.
Primary Outcome Measure Information:
Title
Change in prostate volume measured in cm^3
Description
Change in prostate volume measured with trans-rectal ultrasound at baseline versus prostate volume measured with KVCT and MVCT.
Time Frame
One month post implant
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male 50-80 years of age Eligible for interstitial brachytherapy implants
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William St. Clair, MD
Organizational Affiliation
Lucille P. Markey Cancer Center at University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Application of Megavoltage Imaging to Reduce Artifact After Seed Implants
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