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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01674582

Enrollment

150

Registered

2012-08-29

Start date

2012-10-31

Completion date

2019-12-31

Last updated

2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Tumor

Keywords

Glioma, Brain tumors, Brain metastases, MRI, Cognitive measurement, Neuropsychological evaluation, DW-MRI, P-MRI, MRS

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.

Interventions

OTHERMRI, neuropsychological evaluation, blood sampling

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Early prediction of treatment response based on MRI parameters.	Three weeks compared to baseline.

Secondary

Measure	Time frame	Description
Neuropsychological function.	Month 3, 12, and 18 compared to baseline	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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026