To create a clinical workflow for advanced MRI techniques, which includes image acquisition, analysis, and planning of targeted biopsies based on the resulting images; and to validate the clinical use of advanced MRI techniques by correlating…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The correlation of advanced MRI biomarkers with proteomics or histopathological
measurements of targeted biopsies in glioma.
Secondary outcome
Overall Survival (OS) and progression free survival (PFS).
Background summary
In this project we propose to develop non-invasive approaches to obtain
quantitative physiological maps of the brain in order to aid diagnosis and
monitor the progression and treatment of glioma. We aim to validate advanced
physiological MRI scans for the non-invasive mapping of the heterogeneous
tumour environment, which in turn is important for aiding diagnosis and
follow-up of patients - either in tumour progression or even in therapy
follow-up. This requires extending the clinical scanning time as well as
obtaining samples from the most aggressive place within the brain tumour via
stereotactic biopsies.
Study objective
To create a clinical workflow for advanced MRI techniques, which includes image
acquisition, analysis, and planning of targeted biopsies based on the resulting
images; and to validate the clinical use of advanced MRI techniques by
correlating advanced MRI biomarkers of in human glioma with histopathological
and proteomics measurements of targeted biopsies.
Study design
Prospective, observational, cohort study.
Study burden and risks
First, in addition to the standard clinical care scan of 30 minutes, the
scanning time will be extended 30 minutes longer to acquire biomarkers under
the application of advanced MRI techniques. This means that the scan time in
total becomes 60 minutes. Second, to validate the novel biomarkers, we need at
most four samples taken from the brain tumour via stereotactic biopsies. This
means that the surgical time of the patient will be extended by 30 minutes, as
estimated by neurosurgeons. No other additional observations will be done or no
additional medical actions will be taken in the context of this study. *
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Individuals of 18 years or older
- Referred for surgery for resection or biopsy of brain tumour, including
meningioma and glioma patients.
- Referred for surgery for resection or biopsy of brain metastasis.
- Written informed consent conform ICH-GCP
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 | NL71741.078.19 |