An interventional study of Magnetic resonance imager linear accelerator in Bone Metastases, sponsored by Nucletron Operations BV. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by Nucletron Operations BV · Not applicable, Interventional, and Treatment
Investigational device is the Magnetic resonance imager linear accelerator. Five (5) patients with bone metastases will be treated with palliative intention in this study. The goal is to confirm the pre-clinically demonstrated technical accuracy and safety of the newly developed MR-Linac in the clinical setting.
This is a single center prospective proof of concept study including accuracy and safety aspects according to R-IDEAL stage 1 criteria. Five (5) patients with bone metastases will be treated with palliative intention in this study. Treatment will consist of a single fraction.
The MR linear accelerator (MRL) integrates a radiotherapy accelerator and a diagnostic quality 1.5T MRI, enabling soft-tissue visualization during the actual radiation delivery for improved targeting. This enables on-line treatment optimization for precise radiation delivery. Better visualization of the tumour targets and the surrounding healthy tissues, at the exact moment of treatment, makes it possible to adapt the dose to the actual anatomy while optimally sparing normal tissues.
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Single arm study, 5 patient with bone metastasis will be enrolled for palliative treatment with the Magnetic resonance imager linear accelerator (MR-Linac).
Device: Magnetic resonance imager linear accelerator
The MR linear accelerator (MRL) integrates a radiotherapy accelerator and a diagnostic quality 1.5T MRI, enabling soft-tissue visualization during the actual radiation delivery for improved targeting. This enables on-line treatment optimization for precise radiation delivery. Better visualization of the tumour targets and the surrounding healthy tissues, at the exact moment of treatment, makes it possible to adapt the dose to the actual anatomy while optimally sparing normal tissues.
Also known as: MR-Linac, Unity
Safety of the treatment system (a dose distribution accuracy ≤ 5% will be considered acceptable). Incidence of acute toxicity (CTCAE grade 2 are higher) and incidence of Serious (unexpected) Adverse Events will be measured.
Safety of the system: System behaves in accordance with the workflow and risk mitigation plan, Dosimetric safety: An independent dosimetry check before start irradiation (Oncentra) and an independent dosimetry during irradiation (second chamber) will be used. For the overall process a dose distribution accuracy ≤ 5% will be considered acceptable. Patients safety: by reporting any acute toxicity \> grade 2 (according CTCAE version 4.0 for acute toxicity) and any Serious (Unexpected) Adverse Events (S(U)AE) within 12 weeks after treatment
Time frame: During treatment (Day 0). For patient safety patients will be contacted at day 1, week 2 and week 12 after treatment.
Geometrical accuracy of targeting by online MR imaging
Geometrical accuracy: will be checked online by using the MRI in combination with VolumeTool visualization and off-line by comparison of the EPID beam data with the prescribed beam data. A positioning error of ≤ 5 mm will be considered acceptable
Time frame: During treatment (day 0)
Descriptive analysis of the clinical workflow by keeping a log book for the entire procedure.
Feasibility of the clinical workflow: by keeping a log book for the entire procedure. The validation of radiation delivery includes assessing the hardware performance and the See-Plan-Treat work flow for on-line MRI guided adaptive radiotherapy.
Time frame: During treatment (day 0)
Patients comfort
Patient comfort during the MR-Linac treatment: by patient questionnaire.
Time frame: immediately after treatment (day 0)
Plan to share: No
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Nucletron Operations BV