Rapid Response MRI-Guided Palliative Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Successful treatment of Metastatic Spinal Cord Compression in a single 1 hour appointment for 80% of patients on the MRL Arm
研究概览
简要总结
The goal of this clinical trial is to understand whether the Magnetic Resonance Linear Accelerator (MRL) could expedite Radiotherapy treatment for Metastatic Cord Compression (MSCC) by removing the need for a planning CT (pCT) scan prior to treatment. Radiotherapy will be delivered in one appointment on the MRL and compared to the standard of care of two appointments: a CT scan and a Radiotherapy appointment.
The main questions it aims to answer are:
- Can the MRL deliver successful treatment of MSCC in a single 1-hour appointment?
- Can the MRL treat participants within 24 hours from the doctor's decision to treat?
- Did it take less time from consent to completion of treatment when patients were treated on the MRL?
- Do the questionnaire scores reflect satisfaction with treatment on the MRL? Researchers will compare treatment on the MRL in one appointment to a group receiving standard of care radiotherapy in two appointments.
Participants in both groups will receive the same prescription of 8Gray (Gy) in one treatment (fraction) delivered with one posterior-anterior beam as per our department policies and national standards.
Participants will be asked to complete an optional questionnaire prior to treatment to monitor the diversity of the study population. This questionnaire is anonymised, no personal data that could identify a participant is collected on this questionnaire.
After treatment participants will be asked to complete an experience questionnaire, to assess treatment experience.
Once the questionnaire is complete active participation in the trial is no longer needed, researchers will monitor participants notes for up to 12 months after treatment to record participant well being and function.
详细描述
Metastatic cord compression occurs in 5-10% of patients with cancer often affected the ends stages of a patient's illness. The benefit of palliation is directly related to the speed of treatment, National Institute of Health and Care Excellence (NICE) guidelines recommend that radiotherapy is given within 24 hours of a decision to treat. A recent audit of the current referrals and pathway showed the average time from consultation to treatment is 2.10 days (SD 12.2 days). This audit concluded the need to improve the speed of access to care.
The current pathway includes a scan for diagnosis (MRI), a visit for a planning CT and time to plan the treatment before treatment delivery. This can take many hours or even days. To provide quicker access to care it is intended to use the MR Linac with an integrated adaptive radiotherapy platform, to deliver a scan, plan and treat model in a single appointment.
Preliminary work has modelled dose differences due to the presence of a magnetic field, known as the electron return effect and developed an MR only workflow using a simple planning technique to enable the online scan, plan and treat model.
The primary objective is to test the feasibility of a one-stop MR guided palliative radiotherapy programme for patients with MSCC.
Secondary objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Confirmed Diagnosis of MSCC
- •Referred for an 8Gy, Single Fraction of Radiotherapy
- •18 years or older.
- •Able to give informed consent in writing or verbally.
- •Willing to complete patient experience questionnaire
- •Willing to have the research team review their case notes for up to 1 year following
排除标准
- •Participant does not have capacity and cannot give informed consent.
- •Any evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, make it undesirable for the patient to participate in the study.
- •Participant is unwilling to allow researchers to access their clinical notes and diagnostic scans.
- •Participant is unwilling to complete an experience questionnaire
- •The participant cannot speak or understand English.
- •Exclusion Criteria MRL arm:
- •Any contraindications to MRI identified after MRI safety screening
- •Unable to tolerate MRI scanning
- •Uncontrolled pain/ poor pain control.
- •MSCC in the cervical spine.
- •More than one vertebral level of compression
结局指标
主要结局
Successful treatment of Metastatic Spinal Cord Compression in a single 1 hour appointment for 80% of patients on the MRL Arm
时间窗: The event is assessed on a single day (within 24hours) over a single appointment. From the time the patient enters the treatment room to the time the radiotherapy beam is completed (Up to 2 hours in length).
"Successful treatment" is defined as the complete delivery of the Radiotherapy treatment beam to the area of Metastatic Spinal Cord Compression. The measurement used to assess appointment length will be time, recorded in hours, minutes and seconds. Time from the patient entering the room to the treatment beam completing.
次要结局
- 80% of patients on the MRL Arm treated within 24 hours from decision to treat(From clinician's referral to the completion of the treatment beam (Assessed for up to 7 days).)
- 80% of patients on the MRL Arm spend less time from consent to completion of treatment when compared to the Standard of Care Arm(From time of treatment consent to completion of the treatment beam (Assessed for up to 7 days))
- 80% of the MRL Arm questionnaire scores reflect satisfaction with the treatment(After completion of Radiotherapy (Within 2 hours of the treatment beam being completed))
- The study population is representative of the population referred for Radiotherapy for Metastatic Spinal Cord Compression.(At the time of enrolment (within 2 hours of signing consent form))