Xray Volume Imaging (Cone Beam CT) - Prostate Cancer
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
To evaluate he feasibility of daily X-ray volume imaging during conformal radiotherapy. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
To provide preliminary data concerning the relative utility of daily X-ray volume image matching compared to fiducial marker image matching. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Xray Volume Imaging (Cone Beam CT) - Prostate Cancer | ||||
| Official Title ICMJE | A Clinical Study of X-Ray Volume Imaging to Evaluate the Daily Set-Up Accuracy of Conformal Prostate Radiotherapy | ||||
| Brief Summary | Conformal dose escalated radiotherapy was adopted as the standard treatment technique at PMH for intermediate risk patients with localised disease in 1997. This technique provides a much smaller margin of error for treatment set-up and delivery than with conventional techniques. One way to ensure the accuracy of treatment delivery is to image the prostate position daily, prior to therapy, to allow for appropriate set-up corrections. To do so, imaging markers are implanted into the prostate under guided ultrasound (a standard procedure at PMH). However, there are disadvantages in using imaging markers which include added time to the treatment planning process, and an invasive procedure with a potential for discomfort, bleeding and infection. This study will investigate and compare X-ray volume imaging to the gold standard imaging markers. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Prostatic Neoplasms | ||||
| Intervention ICMJE | Procedure: daily Xray volume imaging for planning radiotherapy | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | November 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00188799 | ||||
| Other Study ID Numbers ICMJE | UHN REB 03-0483-CE, Abbott-CARO Uro-OncologicAward | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Health Network, Toronto | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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