Status:
COMPLETED
First-In Man (FIM) Study MR-Linac
Lead Sponsor:
Nucletron Operations BV
Collaborating Sponsors:
Factory CRO for Medical Devices B.V.
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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 pall...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03284619
Start Date
April 1 2017
End Date
September 8 2017
Last Update
March 29 2018
Active Locations (1)
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1
University Medical Centre Utrecht
Utrecht, Netherlands, 3584 CX