Sperimentazione Clinica Del Sistema INSIDE - Innovative SolutIons for DosimEtry in Hadrontherapy - Per il Monitoraggio Del Trattamento in Adroterapia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- particles ranges
研究概览
简要总结
The study aim is to test the clinical feasibility and effectiveness of an online qualitative monitoring device named INSIDE system during hadrontherapy treatments.
This instrumentation is composed by detectors able to acquire secondary signals generated by the interaction of the primary beam with human tissues. From these measurements performed during irradiation, the INSIDE system estimates the particle beam range inside the patient's body and check the compliance of the ongoing treatment with the clinical prescription, with the aim to optimize the delivered dose.
The study aims to longitudinally monitor patients treated with hadrontherapy at the Italian National Centre of Oncological Hadrontherapy (CNAO) in Pavia in order to:
- evaluate the stability of the INSIDE system response and the significance of the monitoring measurement;
- study the clinical tolerances between ongoing and prescribed treatments within which the differences in particle range are not clinically relevant;
- assess what impact an instrument such as the INSIDE system can have on the clinical routine;
- evaluate the benefits of such a monitoring system with respect to treatment planning constraints.
详细描述
A treatment monitoring instrumentation is highly demanded to maximize the benefits of hadrontherapy from the increased conformation of the released dose to the tumor volume with respect to the conventional radiotherapy.
Since almost all the energy of the charged particles is deposited in the end of their track (Bragg Peak region), the verification of the particle range by experimental measurements, performed during treatment delivery, can help to increase the therapy effectiveness while better sparing healthy tissues.
The INSIDE system is an innovative bi-modal instrumentation consisting of an in-beam Positron Emission Tomography (PET) scanner, to detect annihilation photons coming from positron isotope emitters, and a Dose Profiler to collect signals from charged particles emitted during treatment (e.g. protons in the case of carbon ion treatments).
The in-beam PET scanner is composed by two opposite panels of detectors placed above and below the patient bed, respectively. The Dose Profiler is positioned above the patient with an angle of 60°, forwardly with respect to the beam direction.
The INSIDE system is a passive instrumentation, i.e. no additional dose has to be released to the patient for particle range verification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients treated at CNAO with protons or carbon ions with horizontal beam line.
- •meningioma, ACC, skull base (clivus) chordoma, squamous cellular rhinopharynx carcinoma
- •full compatibility of the INSIDE monitoring system with all beam delivery devices in the established irradiating position
- •all emergency procedures are possible notwithstanding INSIDE system positioned.
- •signed written informed consent by patient.
- •Exclusion Criteria
- •missing informed consent
- •not affected by one of the selected pathologies
- •failure of pre-treatment compatibility technical assessment
- •failure of pre-treatment emergency procedures check
- •medical or individual reasons (i.e. short time test needed)
排除标准
- 未提供
结局指标
主要结局
particles ranges
时间窗: average of 5 weeks (as a treatment duration)
evaluate the quality of treatments in term of data collection and of particles range evaluated with PET scanner and Monte Carlo simulations
particles ranges for each pathology considered
时间窗: 4 months
statistical analysis to assess the evaluations of treatment
次要结局
未报告次要终点