Primary: To test the feasibility of multiple techniques / software for MR-guided adaptive radiation therapy on the Elekta Unity MRL.Secondary: To register acute grade >= 3 toxicity.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To test the feasibility of multiple techniques/software for MR-guided adaptive
radiotherapy on the Elekta Unity MRL system.
Secondary outcome
Treatment associated >= grade 3 acute toxicity according to the NCI Common
Terminology Criteria of Adverse Events (CTCAE version 4.03).
Background summary
CE labelling of the Elekta Unity will mark the clinical start of MR-guided
treatment of patients at the NKI-AVL. Within the Elekta workflow, software will
be provided for registration and adaptation. To have full access to all our
current functionality and meet our high standards of clinical practice, we
intend to use the Elekta workflow as a starting point in which we will
incorporate part of our currently used (XVI) software. Moreover, both Elekta
and the NKI-AVL will expand the technical development of MR-guided radiotherapy
after the clinical introduction and will gradually implement new software and
techniques in the existing workflow for guidance and adaptation for further
improvement. The proposed protocol aims to determine feasibility of multiple
new techniques and software for MR-guided adaptive radiation therapy. For each
proposed technique feasibility has to be determined individually.
Study objective
Primary: To test the feasibility of multiple techniques / software for
MR-guided adaptive radiation therapy on the Elekta Unity MRL.
Secondary: To register acute grade >= 3 toxicity.
Study design
The proposed protocol is a prospective, non-randomized, basket- and umbrella
trial. Patients will be enrolled in multiple parallel cohorts, and will be
treated with evolving techniques for treatment guidance and adaptation.
Each new cohort will be defined by a tumor type(s) and a specific technical
design/software program that will be added. Techniques that will be tested for
feasibility in this protocol include, but are not limited to: XVI registration
software, 4D MRI workflow for liver metastases, 4D MRI workflow for lung
carcinomas, XVI multi-ROI registration, Library of Plan with manual plan
selection for rectal carcinomas, Library of Plan for bladder carcinomas, and
motion compensation by trailing. For each technique a specific study manual is
available.
Intervention
Radiotherapy
Study burden and risks
The Elekta Unity MRL system is an investigational device with CE labeling and
fully commissioned to be used clinically, that will develop continuously over
time by implementation of new software by Elekta and by software developed at
the NKI. It incorporates a 1.5 Tesla diagnostic-quality MRI scanner,
manufactured by Philips Healthcare, which is integrated in the linear
accelerator system. Technical feasibility of software for guidance and
adaptation will be tested within the provided Elekta workflow. For each
technical design or software product that will be tested a specific study
manual will be available, including safety issues per technique.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
• Patient, age >= 18 years, treated with radiation therapy on the MR-Linac.
• WHO performance 0-2.
• Ability to understand and the willingness to sign a written informed consent
document.
Exclusion criteria
• Contra*indications for an MRI examination.
• Patient is pregnant.
• Claustrophobia.
• Patients >140 kg and/or a body width > 60 cm.
• Patients with any other clinically significant medical condition which makes
it undesirable for the patient to participate in the study or which could
jeopardize compliance with study requirements or severe psychiatric
illness/social situation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65953.031.18 |