To diagnose the clinically relevant molecular profile of brain tumours with multimodal quantitative MR imaging, and to stratify patients into several classes of distinctly different molecular and prognostic profiles.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy (true / false positive / negative) in identification of
Class 3 patients using structural and physiological MRI.
Secondary outcome
na
Background summary
In this project we propose to develop a diagnostic approach to noninvasively
predict prognosis and support personalised treatment decisions in patients with
primary brain tumours. Overall survival in these patients varies widely, from
less than a year to over 14 years. It has recently become clear that prognosis
is strongly associated with the tumour*s molecular profile. In this project we
link quantitative MR imaging characteristics, acquired with advanced and
innovative MR imaging techniques, with tumour molecular profiles using a novel
approach called radiogenomics, in combination with advanced image analysis
techniques. With this noninvasive approach, tissue will no longer be required
to predict prognosis, and brain tumour biopsy for this purpose can be obviated
Study objective
To diagnose the clinically relevant molecular profile of brain tumours with
multimodal quantitative MR imaging, and to stratify patients into several
classes of distinctly different molecular and prognostic profiles.
Study design
Prospective, observational, cohort study.
Study burden and risks
The identification of the molecular profiles of this tumour has important
implications for patient management, treatment and follow-up. However, these
molecular profiles can for now only be diagnosed through brain surgery, which
means that patients are * sometimes unnecessarily * put at risk of surgical
complications, or * if no surgery is performed * managed without any knowledge
of the tumour molecular profile.
In this project we aim to provide an accurate prediction of tumour profile at
the presurgical
stage. This has the following highly relevant implications; appropriate timing
of surgery, improved prediction of prognosis and early detection of changes in
tumour behavior.
Except for a prolonged MRI scanning time of ~25 minutes, the burden and risks
of participating in this study are negligible. No additional observations will
be done or no additional medical actions will be taken in the context of this
study.
For a select number of patients an extra biopsy will be taken during the
operation. This will prolong the operation with max. 30 minutes. The additional
risks of this procedure (bleeding) are low, since non-functional tissue will be
biopsied that will be resected right after the procedure.
's Gravendijkwal 210
Rotterdam 3015 CE
NL
's Gravendijkwal 210
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Individuals of 18 years or older
- Referred for surgery (resection or biopsy) of a primary brain tumour
- Written informed consent
Exclusion criteria
- Contra-indication for MRI (implanted metal parts, e.g. stents, vascular clips, pacemakers)
- Inability to give 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 | NL59102.078.16 |