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Quantification of Respiratory-induced Prostate Motion

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ClinicalTrials.gov Identifier: NCT00980993
Recruitment Status : Withdrawn (Lack of enrollment.)
First Posted : September 21, 2009
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Oregon Health and Science University

Tracking Information
First Submitted Date September 19, 2009
First Posted Date September 21, 2009
Last Update Posted Date November 4, 2019
Study Start Date September 2012
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2019)
Motion amplitude [ Time Frame: Continuously during radiation administration (generally 8 to 15 minutes in duration) ]
Measured at frequency of 10Hz
Original Primary Outcome Measures Not Provided
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 Quantification of Respiratory-induced Prostate Motion
Official Title Pilot Study on the Quantification of Respiratory-induced Prostate Motion During Radiation Therapy Using Continuous Real-time Tracking
Brief Summary Patient anatomy and position during the course of radiation therapy can vary from those used for treatment planning; a function of patient movement, uncertainty in positioning system, and organ motion. Traditionally, treatment margins are designed to compensate for interfraction prostate setup variability. This approach has the potential to lower the overall effectiveness of treatment because the prostate gland is a continuously moving target whose motion cannot be accurately accounted for solely on the basis of interfraction movement. More recently, the dosimetric relevance of intra-fraction prostate motion has been recognized, and may be compensated for by continuous real-time adaptive radiation therapy afforded by the Calypso 4D Localization System™. In the current study, the investigators propose to characterize intrafraction prostate motion. The investigators hypothesize that intrafraction prostate motion is correlated with respiratory motion.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Localized prostate cancer patients undergoing intensity-modulated radiation therapy.
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Withdrawn
Actual Enrollment
 (submitted: October 31, 2019)
0
Original Actual Enrollment
 (submitted: September 19, 2009)
5
Estimated Study Completion Date September 2014
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Histologically confirmed stage I-III adenocarcinoma of the prostate gland
  • Age > 18 years. Males of all races and ethnic groups
  • Scheduled to receive radiation for definitive therapy
  • Three (3) electromagnetic transponders implanted into prostate gland

Exclusion Criteria:

  • Does not satisfy inclusion criteria
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (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 NCT00980993
Other Study ID Numbers OHSU IRB00005606
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Oregon Health and Science University
Study Sponsor Oregon Health and Science University
Collaborators Not Provided
Investigators
Principal Investigator: James A. Tanyi, Ph.D. Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date October 2019