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Quantification of Respiratory-induced Prostate Motion

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ClinicalTrials.gov Identifier: NCT00980993
Recruitment Status : Unknown
Verified September 2009 by Oregon Health and Science University.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2009
Last Update Posted : September 22, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Prostate Cancer

Study Design

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study on the Quantification of Respiratory-induced Prostate Motion During Radiation Therapy Using Continuous Real-time Tracking
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Localized prostate cancer patients undergoing intensity-modulated radiation therapy.
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
Contacts and Locations

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): NCT00980993


Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: James A. Tanyi, Ph.D. Oregon Health and Science University
More Information

Additional Information:
Responsible Party: James A. Tanyi, Ph.D., Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00980993     History of Changes
Other Study ID Numbers: OHSU IRB00005606
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: September 22, 2009
Last Verified: September 2009

Keywords provided by Oregon Health and Science University:
Prostate
Motion
Respiration