Clinical trial · Interventional
Continuous Monitoring of Prostate Position During Radiotherapy
Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)
NCT01742403CI-TRIAL-00102649KIM Gatingactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R/T gating kV intrafraction monitoring | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R/T gating kV intrafraction monitoring
- description
- 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).
- interventionNames
- Radiation: R/T gating kV intrafraction monitoring
Primary outcomes (1)
- measure
- Feasibility of KIM techique
- timeFrame
- 10 years
- description
- Technique will be determined as feasible if 90% of treatment fractions are successfully segmented in real time.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (2)
- RESULTKeall 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 guidance method. Med Phys. 2015 Jan;42(1):354-8. doi: 10.1118/1.4904023. PMID 25563275
- RESULTNg 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. PMID 25370626