Prostate Cancer Clinical Trial
— KIM GatingOfficial title:
Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)
This study is investigating measurement of prostate motion during radiotherapy using the implanted gold markers. If motion is greater than 3mm then the beam will be stopped and position corrected (gating).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2028 |
Est. primary completion date | June 30, 2028 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients undergoing definitive external beam radiotherapy; - Histological proven prostate adenocarcinoma - Prostate Specific Antigen (PSA),within 3 months prior to enrolment - Patient must be able to have gold fiducial markers placed in the prostate (if on anticoagulants, must be approved for procedure by Cardiologist) - Artificial hips - Lymph Node irradiation - Patient Dimensions >40cms - ECOG 0-2 - Ability to understand and willingness to sign informed consent form. Exclusion Criteria: - Altered fractionation - Fiducials must be no less than 1cm apart |
Country | Name | City | State |
---|---|---|---|
Australia | Department of Radiation Oncology, Northern Sydney Cancer Centre | St. Leonards | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Royal North Shore Hospital |
Australia,
Keall PJ, Aun Ng J, O'Brien R, Colvill E, Huang CY, Rugaard Poulsen P, Fledelius W, Juneja P, Simpson E, Bell L, Alfieri F, Eade T, Kneebone A, Booth JT. The first clinical treatment with kilovoltage intrafraction monitoring (KIM): a real-time image guida — View Citation
Ng JA, Booth JT, O'Brien RT, Colvill E, Huang CY, Poulsen PR, Keall PJ. Quality assurance for the clinical implementation of kilovoltage intrafraction monitoring for prostate cancer VMAT. Med Phys. 2014 Nov;41(11):111712. doi: 10.1118/1.4898119. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of KIM techique | Technique will be determined as feasible if 90% of treatment fractions are successfully segmented in real time. | 10 years | |
Secondary | Time for procedure | Measurement of time taken to perform KIM gating to guide future department resource questions. | 10 years |
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