First-In Man (FIM) Study MR-Linac

NCT03284619 | Completed

• 2 other identifiers: MR-Linac-CIP-001 Version 2.0NL60984.041.17
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (2)

• 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.

  Safety of the system: System behaves in accordance with the workflow and risk mitigation plan, Dosimetric safety: An independent dosimetry check before start irradiation (Oncentra) and an independent dosimetry during irradiation (second chamber) will be used. For the overall process a dose distribution accuracy ≤ 5% will be considered acceptable. Patients safety: by reporting any acute toxicity \> grade 2 (according CTCAE version 4.0 for acute toxicity) and any Serious (Unexpected) Adverse Events (S(U)AE) within 12 weeks after treatment

  During treatment (Day 0). For patient safety patients will be contacted at day 1, week 2 and week 12 after treatment.

• Geometrical accuracy of targeting by online MR imaging

  Geometrical accuracy: will be checked online by using the MRI in combination with VolumeTool visualization and off-line by comparison of the EPID beam data with the prescribed beam data. A positioning error of ≤ 5 mm will be considered acceptable

  During treatment (day 0)

Secondary Outcomes (2)

• Descriptive analysis of the clinical workflow by keeping a log book for the entire procedure.

  During treatment (day 0)

• Patients comfort

  immediately after treatment (day 0)

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Device: Magnetic resonance imager linear accelerator

Interventions

Magnetic resonance imager linear accelerator DEVICE

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.

Also known as: MR-Linac, Unity

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nucletron Operations BV: lead
• Factory CRO for Medical Devices B.V.: collaborator

Study Sites (1)

University Medical Centre Utrecht

Utrecht, 3584 CX, Netherlands

Location

Study Officials

• Ina Jürgenliemk-Schulz, MD, PhD

  UMCU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Proof of concept including accuracy and safety aspects according to R-IDEAL stage 1 criteria

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: September 15, 2017
• Study Start: April 1, 2017
• Primary Completion: July 11, 2017
• Study Completion: September 8, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)