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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01674582
Other study ID # Version1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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