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Completed

NCT Number: NCT03284619

First-In Man (FIM) Study MR-Linac

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.

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Key information

Conditions

Bone Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Utrecht

Utrecht, 3584 CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In order to be eligible to participate in this study, a patient must meet all of the following criteria:

  • Painful bone metastases in the lumbar spine
  • Radiographic evidence of bone metastases
  • Histologic proof of malignancy (primary carcinoma)
  • Karnofsky Performance Score ≥ 50
  • Age ≥ 18 years
  • Able to provide written informed consent

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • Prior radiation therapy within the region planned to be irradiated
  • Contraindication for MRI according to screening protocol radiology department UMCU (e.g. cardiac pacemakers, and defibrillators, artificial heart valves or cochlear implants, https://richtlijn.mijnumc.nl/Beeld/MRI/Paginas/MRI-Veiligheid-Contra-indicaties.aspx
  • Claustrophobia
  • Standard systemic anti-cancer therapy or radionuclide therapy within 48 hours before or after treatment.
  • Any other type of not standard systemic anti-cancer treatment, except for endocrine treatment.
  • Unstable spine requiring surgical stabilization
  • Neurological deficit due to bone metastasis

Treatment and study plan

Magnetic resonance imager linear accelerator

Device

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.

Other names: MR-Linac, Unity

Primary outcomes

  1. 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.

    Time frame: During treatment (Day 0). For patient safety patients will be contacted at day 1, week 2 and week 12 after treatment.

    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

  2. Geometrical accuracy of targeting by online MR imaging

    Time frame: During treatment (day 0)

    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

Secondary outcomes

  1. Descriptive analysis of the clinical workflow by keeping a log book for the entire procedure.

    Time frame: During treatment (day 0)

    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.

  2. Patients comfort

    Time frame: immediately after treatment (day 0)

    Patient comfort during the MR-Linac treatment: by patient questionnaire.

Sponsors and collaborators

Lead sponsor

Nucletron Operations BV

Industry

Collaborators

  • Factory CRO for Medical Devices B.V.

Registry information

Acronym: FIM MR-Linac

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2017
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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