Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters

Study Overview
=================
Brief Summary
-----------------
The main purposes with this trial is to investigate the potential of MRI with diffusion and blood volume, flow in brain to diagnose and to measure treatment effects in patients with intracranial tumors, especially gliomas and metastases in a prospective trial, to evaluate the possibilities to individually adjusted treatment in this category of patients depending on treatment outcomes measured by MRI, to perform clinical follow up in connection with MRI to evaluate a correlation and to perform testing of cognitive ability before, during, and after treatment and to investigate if given treatment causes any decrease in the patients habitual state.

Official Title
-----------------
Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters.

Conditions
-----------------
Intracranial Tumor

Intervention / Treatment
-----------------
* Other: MRI, neuropsychological evaluation, blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Suspected primary brain tumor, verified glioblastoma or non surgically treated metastases from solid tumor Increasing MRI changes in patients with previous verified glioblastoma Be able to speak Swedish without difficulties (because of the neuropsychological investigations) Written informed concent Exclusion Criteria: Unability to perform MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI, Neuropsychological testing<br> | Other: MRI, neuropsychological evaluation, blood sampling<br>* MRI at timepoints given above, neuropsychological testing after surgery, but before radiotherapy or chemotherapy. Neuropsychological testing month 3 during treatment. Neuropsychological testing after 1 year. Neuropsychological testing after 2 years.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early prediction of treatment response based on MRI parameters. |  | Three weeks compared to baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological function. | Neuropsychological testing to evaluate the correlation between MRI results and neuropsychological status in participating patients. This applies for 80 patients of 150 of the patient population. | Month 3, 12, and 18 compared to baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioma, Brain tumors, Brain metastases, MRI, Cognitive measurement, Neuropsychological evaluation, DW-MRI, P-MRI, MRS