Bone MetastasesFIM MR-LinacNCT03284619
First-In Man (FIM) Study MR-Linac
A study testing Magnetic resonance imager linear accelerator in people with Bone Metastases, run by Nucletron Operations BV at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Magnetic resonance imager linear accelerator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2017to 8 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bone Metastases
- Being tested
- Magnetic resonance imager linear accelerator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imager linear acceleratorDevice
Also called MR-Linac, Unity
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Single arm study, 5 patient with bone metastasis will be enrolled for palliative treatment with the Magnetic resonance imager linear accelerator (MR-Linac). Receives: Device: Magnetic resonance imager linear accelerator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During treatment (day 0)
Secondary outcomes (2)
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.
Measured: During treatment (day 0)
Patients comfort
Patient comfort during the MR-Linac treatment: by patient questionnaire.
Measured: immediately after treatment (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start1 Apr 2017
- Primary completion11 Jul 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof of concept including accuracy and safety aspects according to R-IDEAL stage 1 criteria
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucletron Operations BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Factory CRO for Medical Devices B.V.
- Responsible party
- Sponsor
- Investigators
- Ina Jürgenliemk-Schulz, MD, PhD, Principal investigator, UMCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284619
- Sponsor's protocol ID
- MR-Linac-CIP-001 Version 2.0
- Other IDs
- NL60984.041.17
- Acronym
- FIM MR-Linac
- Status last verified
- Mar 2018
- First submitted
- 22 Jun 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In Man (FIM) Study MR-Linac
- ClinicalTrials.gov ID
- NCT03284619
- Acronym / sponsor ID
- FIM MR-Linac / MR-Linac-CIP-001 Version 2.0
- Conditions
- Bone Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nucletron Operations BVIndustry (pharma, biotech, devices)
- Collaborators
- Factory CRO for Medical Devices B.V.
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof of concept including accuracy and safety aspects according to R-IDEAL stage 1 criteria
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Device: Magnetic resonance imager linear acceleratorSingle arm study, 5 patient with bone metastasis will be enrolled for palliative treatment with the Magnetic resonance imager linear accelerator (MR-Linac). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imager linear acceleratorAlso: MR-Linac, UnityThe 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. | Device | treatment arm |
Primary outcome
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
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
2 secondary outcomes
Descriptive analysis of the clinical workflow by keeping a log book for the entire procedure.
Time frame: During treatment (day 0)
Patients comfort
Time frame: immediately after treatment (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ina Jürgenliemk-Schulz, MD, PhD principal investigator
UMCU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imager linear accelerator in people with Bone Metastases, run by Nucletron Operations BV at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.