Intracranial TumorNCT01674582
Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters
A study testing MRI, neuropsychological evaluation, blood sampling in people with Intracranial Tumor, run by Lund University Hospital at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Tumor
- What is being tested?
- MRI, neuropsychological evaluation, blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unability to perform MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intracranial Tumor
- Being tested
- MRI, neuropsychological evaluation, blood sampling
- Keywords
- Glioma, Brain tumors, Brain metastases, MRI, Cognitive measurement, Neuropsychological evaluation, DW-MRI, P-MRI, MRS
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI, neuropsychological evaluation, blood samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MRI, Neuropsychological testing | Other | Not described Receives: Other: MRI, neuropsychological evaluation, blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early prediction of treatment response based on MRI parameters.
Measured: Three weeks compared to baseline.
Secondary outcomes (1)
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.
Measured: Month 3, 12, and 18 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startOct 2012
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pia Maly Sundgren, MD. PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674582
- Sponsor's protocol ID
- Version1.0
- Status last verified
- Sep 2020
- First submitted
- 23 Jan 2012
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters.
- ClinicalTrials.gov ID
- NCT01674582
- Acronym / sponsor ID
- Version1.0
- Conditions
- Intracranial Tumor
- Keywords
- Glioma, Brain tumors, Brain metastases, MRI, Cognitive measurement, Neuropsychological evaluation, DW-MRI, P-MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI, Neuropsychological testing | Other | Other: MRI, neuropsychological evaluation, blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unability to perform MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI, neuropsychological evaluation, blood samplingMRI 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. | Other | MRI, Neuropsychological testing |
Primary outcome
Early prediction of treatment response based on MRI parameters.
Time frame: Three weeks compared to baseline.
1 secondary outcome
Neuropsychological function.
Time frame: Month 3, 12, and 18 compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia Maly Sundgren, MD. PhD principal investigator
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, neuropsychological evaluation, blood sampling in people with Intracranial Tumor, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early prediction of treatment response based on MRI parameters. (time frame: Three weeks compared to baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.