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First-In Man (FIM) Study MR-Linac (FIM MR-Linac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284619
Recruitment Status : Completed
First Posted : September 15, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Factory CRO for Medical Devices B.V.
Information provided by (Responsible Party):
Nucletron Operations BV

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bone Metastases Device: Magnetic resonance imager linear accelerator Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Proof of concept including accuracy and safety aspects according to R-IDEAL stage 1 criteria
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-In Man (FIM) Study MR-Linac
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : July 11, 2017
Actual Study Completion Date : September 8, 2017

Arm Intervention/treatment
Experimental: treatment arm
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.
Other Names:
  • MR-Linac
  • Unity




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284619


Locations
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Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Nucletron Operations BV
Factory CRO for Medical Devices B.V.
Investigators
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Principal Investigator: Ina Jürgenliemk-Schulz, MD, PhD UMCU
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Responsible Party: Nucletron Operations BV
ClinicalTrials.gov Identifier: NCT03284619    
Other Study ID Numbers: MR-Linac-CIP-001 Version 2.0
NL60984.041.17 ( Other Identifier: CCMO )
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes