Continuous Monitoring of Prostate Position During Radiotherapy (KIM Gating)
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|ClinicalTrials.gov Identifier: NCT01742403|
Recruitment Status : Recruiting
First Posted : December 5, 2012
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: R/T gating kV intrafraction monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)|
|Actual Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: R/T gating kV intrafraction monitoring
Intervention: Recruitment will be performed in 2 phases:
Phase I will include the first 10 patients. All patients will be treated on a standard fractionation protocol with 40 fractions. This will allow 400 potential fractions to be auto-segmented in real time. Once Phase I is successfully completed we will aim to continue recruitment of a further 20 patients as Phase II. For this phase we will open recruitment to patients with lymph node positivity, hypofractionation (as per Department protocols) and intermittent imaging (imaging less frequently than every fraction).
Radiation: R/T gating kV intrafraction monitoring
This is a Phase I Pilot study to assess the feasibility of implementing prostate radiotherapy gating using kV intrafraction monitoring.
- Feasibility [ Time Frame: 2 years ]Technique will be determined as feasible if 90% of treatment fractions are successfully segmented in real time.
- Time for procedure [ Time Frame: 2 years ]Measurement of time taken to perform KIM gating to guide future department resource questions.
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): NCT01742403
|Contact: Thomas N Eade, MBBS||+61294631319||TEade@nsccahs.health.nsw.gov.au|
|Contact: Jeremy Booth, PhD||+61294631320||JBooth@nsccahs.health.nsw.gov.au|
|Australia, New South Wales|
|Department of Radiation Oncology, Northern Sydney Cancer Centre||Recruiting|
|St. Leonards, New South Wales, Australia, 2065|
|Contact: Thomas N Eade, MBBS +61294631315 Thomas.Eade@health.nsw.gov.au|
|Contact: Carol Kwong, RN +61 2 9463 1339 Carolyn.Kwong@health.nsw.gov.au|
|Principal Investigator: Thomas N Eade, RANZCR I & II|
|Principal Investigator:||Thomas Eade, MBBS||Royal North Shore Hospital|