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

Nucletron

Status: Completed

Conditions: Bone Metastases

Treatments: Device: Magnetic resonance imager linear accelerator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03284619

MR-Linac-CIP-001 Version 2.0

NL60984.041.17 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

treatment arm

Experimental group

Description:

Single arm study, 5 patient with bone metastasis will be enrolled for palliative treatment with the Magnetic resonance imager linear accelerator (MR-Linac).

Treatment:

Device: Magnetic resonance imager linear accelerator