Generate proof-of-concept of using a physiological CTV for radiotherapy treatment planning for patients with brain tumours.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Equal prediction of pattern of failure (locations of tumour recurrence) based
on the physiological CTV compared to the standard CTV used for radiotherapy
planning, with the physiological CTV being smaller in volume.
Secondary outcome
NA
Background summary
Current treatment management of patients with IDH-wildtype glioblastoma is
sub-optimal because of two main issues: (1) Creating an accurate target volume
for radiotherapy, a key aspect of glioblastoma treatment, containing all
remaining tumour cells after surgery that is impossible with the conventional
CT and MRI imaging techniques currently used and (2) in the follow-up of
patients after radiotherapy, conventional MRI is incapable of distinguishing
tumour progression from treatment effects. The solution to these issues lies in
accurate and non-invasive assessment of physiological processes of tumour cells
to enable delineation of the true physiological clinical target volume (CTV)
for radiotherapy planning and to allow for early detection of true tumour
progression during treatment follow-up.
Study objective
Generate proof-of-concept of using a physiological CTV for radiotherapy
treatment planning for patients with brain tumours.
Study design
By extending the clinical standard MRI session used for radiotherapy planning
in patients diagnosed with glioblastoma with advanced MRI techniques that
assess oxygenation status and cell proliferation, a physiological CTV will be
generated for each patient in addition to the standard CTV. Treatment for each
patient will be according to the current standard in which the standard CTV is
used. Initial analysis will include comparing both CTVs in terms of volume and
location. Patient follow-up will occur according to the clinical standard,
including the standard MRI scan protocols, for a maximum of 2 years.
Pattern-of-failure analysis will be done to compare the standard CTV and
physiological CTV. It is hypothesized that the physiological CTV will be
smaller than the standard CTV, whilst having the same pattern-of-failure.
Study burden and risks
The patients the burden of prolonged scan time (+ 30 minutes, scan will last 60
mins in total) during their standard RT planning scan. The remainder of their
clinical care will not be altered: RT will be given to these patients based on
standard CTVs. Follow-up will follow the clinical protocol . There will be no
personal benefit for the patients in this research project.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Informed consent;
• Adults (18 years or older);
• diagnosed with IDH-wildtype GBM, as confirmed by pathology including
molecular analysis post resection/biopsy;
• referred to outpatient clinic of the Department of Radiotherapy to undergo
standard treatment with high-dose RT.
• Patients eligible for 30x2Gy or 15x2.67Gy
Exclusion criteria
• Contraindication for MRI
• Contraindication for use of gadolinium-based contrast agent (i.e. subject
having renal deficiency)
• Unable to give informed consent
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 | NL80747.078.22 |