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

Primary Purpose

Bone Metastases

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Magnetic resonance imager linear accelerator
Sponsored by
Nucletron Operations BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Centre Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

Single arm study, 5 patient with bone metastasis will be enrolled for palliative treatment with the Magnetic resonance imager linear accelerator (MR-Linac).

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2017
Last Updated
March 27, 2018
Sponsor
Nucletron Operations BV
Collaborators
Factory CRO for Medical Devices B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT03284619
Brief Title
First-In Man (FIM) Study MR-Linac
Acronym
FIM MR-Linac
Official Title
First-In Man (FIM) Study MR-Linac
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 11, 2017 (Actual)
Study Completion Date
September 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nucletron Operations BV
Collaborators
Factory CRO for Medical Devices B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Proof of concept including accuracy and safety aspects according to R-IDEAL stage 1 criteria
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
Single arm study, 5 patient with bone metastasis will be enrolled for palliative treatment with the Magnetic resonance imager linear accelerator (MR-Linac).
Intervention Type
Device
Intervention Name(s)
Magnetic resonance imager linear accelerator
Other Intervention Name(s)
MR-Linac, Unity
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Title
Geometrical accuracy of targeting by online MR imaging
Description
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)
Secondary Outcome Measure Information:
Title
Descriptive analysis of the clinical workflow by keeping a log book for the entire procedure.
Description
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)
Title
Patients comfort
Description
Patient comfort during the MR-Linac treatment: by patient questionnaire.
Time Frame
immediately after treatment (day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ina Jürgenliemk-Schulz, MD, PhD
Organizational Affiliation
UMCU
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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First-In Man (FIM) Study MR-Linac

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