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Application of Megavoltage Imaging to Reduce Artifact After Seed Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01810627
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
William St Clair, University of Kentucky

Tracking Information
First Submitted Date March 11, 2013
First Posted Date March 13, 2013
Last Update Posted Date September 26, 2017
Study Start Date September 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2013)
Change in prostate volume measured in cm^3 [ Time Frame: One month post implant ]
Change in prostate volume measured with trans-rectal ultrasound at baseline versus prostate volume measured with KVCT and MVCT.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Prostate Cancer
Intervention Radiation: MVCT
Patients will receive an additional MVCT scan at their one month follow up visit.
Study Groups/Cohorts MVCT
Patients will receive an additional MVCT scan at their one month follow up visit.
Intervention: Radiation: MVCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2013)
10
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Male 50-80 years of age Eligible for interstitial brachytherapy implants

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01810627
Other Study ID Numbers 13-RAD-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party William St Clair, University of Kentucky
Study Sponsor William St Clair
Collaborators Not Provided
Investigators
Principal Investigator: William St. Clair, MD Lucille P. Markey Cancer Center at University of Kentucky
PRS Account University of Kentucky
Verification Date September 2017