Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility of KIM techique
研究概览
简要总结
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).
详细描述
Prostate cancer now accounts for one third of all new cancer diagnoses in men and approximately 30% of men will have external beam radiotherapy as their primary local therapy. Prostate motion during radiotherapy can be divided into interfraction and intrafraction motion. Interfraction motion has been well established and has been largely overcome by daily online image verification with either ultrasound, online CT or implanted fiducial markers, however motion during the radiation beam on time (intrafraction motion) is not corrected and can be the cause of significant errors in radiation dose delivery.
Intrafraction motion: Movement of the prostate after initial treatment setup has been termed intrafraction motion. Estimates of the magnitude and frequency of this motion were initially made using continuous Magnetic Resonance (MR) imaging. Padhani et al reported 16% of patients had > 5mm anterior:posterior motion when imaged for 7 minutes with similar results reported in subsequent MR cine studies, Intrafraction motion can be secondary to organ motion such as bladder filling, respiration or moving rectal gas, or can be due to physical patient motion. With the availability of real-time prostate tracking, clinical data is available to quantify the magnitude and frequency of motion. An early report from Kupelian et al using continuous radiotransponder positioning7 described 41% of fractions with >3mm of motion and 15% > 5mm of motion for > 30 seconds. The risk of motion was noted to increase with longer treatment time.
Our own data using offline autosegmentation of the fiducial marker position of 10 patients showed 38% of fractions >1mm, 4.7% of fractions >3mm and 1.7% of fractions >5mm instantaneously during treatment delivery of approximately 2.5 min 8.
Significance of correcting for motion:
If radiation dose is recalculated for each individual fraction and adjusted for intrafraction motion it is possible to estimate the real dose delivered to the target and compare this to the desired dose. This comparison gives a robust model of the potential benefit for real- time tracking and adjustment for the motion. Overview of kilovoltage intrafraction monitoring (KIM): Kilovoltage intrafraction monitoring is a novel real-time tumour localisation modality. It involves a single gantry- mounted kV x-ray imager (which is widely available on most linacs) acquiring 2D projections of implanted fiducial markers. As the treatment gantry rotates around the patient during treatment , the kV imager acquires 2D projections of the prostate . The fiducial markers are segmented using an in-house developed software package. 3D positions are determined via maximum likelihood estimation (MLE) of a 3D probability density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •Ability to understand and willingness to sign informed consent form.
排除标准
- •Altered fractionation
- •Fiducials must be no less than 1cm apart
研究组 & 干预措施
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).
干预措施: R/T gating kV intrafraction monitoring (Radiation)
结局指标
主要结局
Feasibility of KIM techique
时间窗: 10 years
Technique will be determined as feasible if 90% of treatment fractions are successfully segmented in real time.
次要结局
- Time for procedure(10 years)
研究者
Professor Thomas Eade
Radiation Oncologist
Royal North Shore Hospital
