Clinical trial NCT03284619: First-In Man (FIM) Study MR-Linac
Official title: First-In Man (FIM) Study MR-Linac
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Metastases
Lead sponsor: Nucletron Operations BV
Sponsor class: INDUSTRY
Collaborators: name: Factory CRO for Medical Devices B.V.
First posted: 2017-09-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proof of concept including accuracy and safety aspects according to R-IDEAL stage 1 criteria
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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.
timeFrame: During treatment (Day 0). For patient safety patients will be contacted at day 1, week 2 and week 12 after treatment.
measure: Geometrical accuracy of targeting by online MR imaging
timeFrame: During treatment (day 0)
Secondary outcomes:
measure: Descriptive analysis of the clinical workflow by keeping a log book for the entire procedure.
timeFrame: During treatment (day 0)
measure: Patients comfort
timeFrame: immediately after treatment (day 0)
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
Study officials:
affiliation: UMCU
name: Ina Jürgenliemk-Schulz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: