ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01674582
Recruitment Status : Recruiting
First Posted : August 29, 2012
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intracranial Tumor Other: MRI, neuropsychological evaluation, blood sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : October 2012
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MRI, Neuropsychological testing 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.





Primary Outcome Measures :
  1. Early prediction of treatment response based on MRI parameters. [ Time Frame: Three weeks compared to baseline. ]

Secondary Outcome Measures :
  1. Neuropsychological function. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674582


Contacts
Contact: Pia Maly Sundgren, MD, PhD +46 46 17 10 00 pia.sundgren@med.lu.se
Contact: Sara Kinhult, MD, PhD +46 46 17 75 20 sara.kinhult@med.lu.se

Locations
Sweden
Lund University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Danielle van Westen, MD, PhD    +46 46    danielle.vanwesten@skane.se   
Contact: Sara Kinhult, MD, PhD    +46 46 17 75 20    sara.kinhult@med.lu.se   
Principal Investigator: Danielle van Westen, MD, PhD         
Sponsors and Collaborators
Lund University Hospital
Investigators
Principal Investigator: Pia Maly Sundgren, MD. PhD Skåne University Hospital-Lund

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01674582     History of Changes
Other Study ID Numbers: Version1.0
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Keywords provided by Lund University Hospital:
Glioma
Brain tumors
Brain metastases
MRI
Cognitive measurement
Neuropsychological evaluation
DW-MRI
P-MRI
MRS

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases