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First-In Man (FIM) study MR-Linac

First-In Man (FIM) study MR-Linac - FIM MR-Linac

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45369
Enrollment
5
Registered
2017-04-12
Start date
2017-05-19
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bot metastasen Bone metastases cancer

Interventions

The patient is treated once with a targeted irradiation dose of 8 Gy (8000 msV).

Sponsors

Elekta
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To confirm in the clinical setting: * Safety of the treatment system * Geometrical accuracy of real-time targeted irradiation with real-time MR imaging

Secondary

MeasureTime frame
* Feasibility of the clinical workflow * Patients (dis)comfort

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)