Primary objective: to acquire patient data required to optimize/train a method to generate synthetic CT scans from MRI scans and to determine the suitability of the synthetic CT scans for radiotherapy treatment planning.Secondary objective: To…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hoofd-hals kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: the percentage of patients in the validation cohort for which the
dosimetrical accuracy is within tolerance for at least 80% of the organs and
targets when the synthetic CT is used for dose calculations.
Secondary outcome
Secondary: the percentage of patients in the validation cohort that meet for
80% of the organs the criteria for contouring accuracy, namely that 80% of the
contour points need to be within 2 mm from the gold standard contours.
Background summary
In the Netherlands about 3000 patients are diagnosed with head-and-neck cancer
each year of which the majority is treated with (chemo)-radiotherapy. As part
of the preparation of the radiotherapy treatment, both a CT scan and a MRI scan
are acquired of the patient in treatment position. The MRI scan is acquired to
clearly depict and delineate the tumor while the CT scan is necessary to plan
the radiotherapy treatment beams. The current preparation procedure has a
couple of disadvantages. First, two patient appointments are required for the
CT and MRI scan. Second due to unavoidable slight variations in patient
position at the time of the CT and MRI, both scans need to be registered. Any
misalignment in registration is at the expense of the treatment accuracy.
Third, delineation of the organs at risk is a tedious manual process that can
takes hours per patient.
Within a European consortium funded by EIT Health we are developing a special
type of MRI sequence that can be used to create a synthetic CT scan. We
hypothesize that using this synthetic CT it will no longer be necessary to
acquire a separate CT, avoiding the problems stated above. Moreover the
consortium develops automated tools for contouring based on deep learning that
could be used to automatically delineate organs at risk, possibly saving
considerable preparation time.
Study objective
Primary objective: to acquire patient data required to optimize/train a method
to generate synthetic CT scans from MRI scans and to determine the suitability
of the synthetic CT scans for radiotherapy treatment planning.
Secondary objective: To evaluate if the deep learning based autocontouring can
lead to delineations of organs at risk comparable to those delineated by an
expert radiation-oncologist.
Study design
Technical feasibility study
Study burden and risks
The burden consists of a 15 minutes longer MRI scan time than used in standard
workup: 35 minutes instead of 20 minutes scan time. During the scanning, the
patients wear the radiotherapy immobilization mask required for the clinical
scans. There are no risks associated with the intervention. The study does not
affect the treatment.
Dr.Molewaterplein 40
Rotterdam 3015GD
NL
Dr.Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
-Patients with head-and-neck cancer.
-Scheduled for primary (chemo)radiotherapy where a MRI scan is part of the
standard radiotherapy work up
-Written informed consent.
Exclusion criteria
-Having any physical or mental status that interferes with the informed consent
procedure.
-Contraindications for MRI (e.g. claustrophobia, arterial clips in central
nervous system)
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 | NL71668.078.19 |
Other | NL8167 |