First-In Man (FIM) study MR-Linac

Completed

• Conditions: Bot metastasen; Bone metastases; cancer

• Registration Number: NL-OMON45369
• Lead Sponsor: Elekta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-11-15
• Results First Posted: 2018-01-22
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

* Painful bone metastases in the lumbar spine
* Radiographic evidence of bone metastases
* Histologic proof of malignancy
* Karnofsky Performance Score * 50
* Age * 18 years
* Able to provide a written informed consent

Exclusion Criteria

* 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 chemotherapy or radionuclide therapy within 48 hours before or after treatment
* Any other type of systemic anti-cancer treatment, except for endocrine treatment
* Unstable spine requiring surgical stabilization
* Neurological deficit
* Not able to provide a written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To confirm in the clinical setting:<br /><br>* Safety of the treatment system<br /><br>* Geometrical accuracy of real-time targeted irradiation with real-time MR<br /><br>imaging</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Feasibility of the clinical workflow<br /><br>* Patients (dis)comfort</p><br>