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

NCT01674582 | Completed

• 1 other identifier: Version1.0
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Tumor

Keywords

Glioma; Brain tumors; Brain metastases; MRI; Cognitive measurement; Neuropsychological evaluation; DW-MRI; P-MRI; MRS

Outcome Measures

Primary Outcomes (1)

• Early prediction of treatment response based on MRI parameters.

  Three weeks compared to baseline.

Secondary Outcomes (1)

• Neuropsychological function.

  Month 3, 12, and 18 compared to baseline

Study Arms (1)

MRI, Neuropsychological testing

OTHER

Other: MRI, neuropsychological evaluation, blood sampling

Interventions

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.

MRI, Neuropsychological testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unability to perform MRI

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Lund University Hospital

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Pia Maly Sundgren, MD. PhD

  Skåne University Hospital Lund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: August 29, 2012
• Study Start: October 1, 2012
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

SE (1)