Back to resultsTreatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters
Primary Purpose
Intracranial Tumor
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MRI, neuropsychological evaluation, blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Intracranial Tumor focused on measuring Glioma, Brain tumors, Brain metastases, MRI, Cognitive measurement, Neuropsychological evaluation, DW-MRI, P-MRI, MRS
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
Sites / Locations
- Lund University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI, Neuropsychological testing
Arm Description
Outcomes
Primary Outcome Measures
Early prediction of treatment response based on MRI parameters.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01674582
First Posted
January 23, 2012
Last Updated
September 1, 2020
Sponsor
Lund University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01674582
Brief Title
Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters
Official Title
Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Tumor
Keywords
Glioma, Brain tumors, Brain metastases, MRI, Cognitive measurement, Neuropsychological evaluation, DW-MRI, P-MRI, MRS
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI, Neuropsychological testing
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
MRI, neuropsychological evaluation, blood sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early prediction of treatment response based on MRI parameters.
Time Frame
Three weeks compared to baseline.
Secondary Outcome Measure Information:
Title
Neuropsychological function.
Description
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.
Time Frame
Month 3, 12, and 18 compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Maly Sundgren, MD. PhD
Organizational Affiliation
Skåne University Hospital Lund
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters
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