First-In Man (FIM) Study MR-Linac

Bone Metastases Clinical Trial

— FIM MR-Linac  

Official title:

First-In Man (FIM) Study MR-Linac

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284619
• Other study ID #: MR-Linac-CIP-001 Version 2.0
• Secondary ID: NL60984.041.17
• Status: Completed
• Phase: N/A
• First received: June 22, 2017
• Last updated: March 27, 2018
• Start date: April 1, 2017
• Est. completion date: September 8, 2017

Study information

• Verified date: March 2018
• Source: Nucletron Operations BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 8, 2017
• Est. primary completion date: July 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Centre Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Nucletron Operations BV	Factory CRO for Medical Devices B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During treatment (Day 0). For patient safety patients will be contacted at day 1, week 2 and week 12 after treatment.
Primary	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	During treatment (day 0)
Secondary	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.	During treatment (day 0)
Secondary	Patients comfort	Patient comfort during the MR-Linac treatment: by patient questionnaire.	immediately after treatment (day 0)