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Completed

NCT Number: NCT01674582

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

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.

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Key information

Conditions

Intracranial Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University Hospital

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI, neuropsychological evaluation, blood sampling

Other

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 outcomes

  1. Early prediction of treatment response based on MRI parameters.

    Time frame: Three weeks compared to baseline.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2012
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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