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

Not Applicable

Completed

• Conditions: Intracranial Tumor
• Interventions: Other: MRI, neuropsychological evaluation, blood sampling

• Registration Number: NCT01674582
• Lead Sponsor: Lund University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-08-24
• Study First Posted: 2012-08-29
• Study Start: 2012-10
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI, Neuropsychological testing	MRI, neuropsychological evaluation, blood sampling	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Lund University Hospital; 🇸🇪 Lund, Sweden