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

Intracranial Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674582
• Other study ID #: Version1.0
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Tumor

Intervention

Other:
• MRI, 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.

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early prediction of treatment response based on MRI parameters.		Three weeks compared to baseline.
Secondary	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