GliomasNCT01225003
Advanced MR Techniques in Detection of Tumor Infiltration and Grading in Gliomas
An observational study of Gliomas, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection of microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in optimal choice and planning of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gliomas
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2010to not given
- Phase
- Observational
- 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
Study population: patients diagnosed with a gliomatuous brain tumor, prior to treatment
Who may be able to join
- diagnosis of gliomatous brain tumour
Who cannot join
- younger than 18 years of age
- prior treatment
- history of neurological or neurosurgical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diffusion Kurtosis Imaging en MR Spectroscopy in Grading and the Characterization of Tumour Infiltration in Gliomas
In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection of microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in optimal choice and planning of treatment.
Patients treated with gliomatous brain tumours are included voluntarily. They undergo one imaging session on a 3T MR scanner prior to treatment.
Read more
DKI data are quantitively analyzed in order to estimate specific parameters in normal appearing white matter, grey matter, tumor and peritumoral edema. MRS data are analyzed quantitatively and qualitatively with peak integration, ratio calculation and classification algorithms. Histological confirmation is obtained at subsequent surgery.
Information from this study can be of significant importance in avoiding brain biopsies. Furthermore, information on microscopic tumour spread can be used during neurosurgery or in radiotherapy planning. An important advantage of these advanced MR techniques is the non-invasivity and the lack of ionizing radiation, two important issues in this relatively young patient population.
- Conditions
- Gliomas
- Keywords
- gliomas, magnetic resonance, diffusion kurtosis imaging, MR spectroscopy, grading
- Medical subject headings
- Glioma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomasStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Sunaert, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenUwe Himmelreich, PhD, Principal investigator, Catholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225003
- Sponsor's protocol ID
- S52302
- Status last verified
- Oct 2010
- First submitted
- 19 Oct 2010
- Last updated
- 29 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Kurtosis Imaging en MR Spectroscopy in Grading and the Characterization of Tumour Infiltration in Gliomas
- ClinicalTrials.gov ID
- NCT01225003
- Acronym / sponsor ID
- S52302
- Conditions
- Gliomas
- Keywords
- gliomas, magnetic resonance, diffusion kurtosis imaging, MR spectroscopy, grading
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2010
- First posted
- 20 Oct 2010 (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.
In this study, we evaluate the role of diffusion kurtosis imaging (DKI) and MR spectroscopy (MRS), two advanced imaging techniques in magnetic resonance (MR) in grading and detection of microscopic infiltrating tumour in gliomas. These parameters are of utmost importance in optimal choice and planning of treatment.
Patients treated with gliomatous brain tumours are included voluntarily. They undergo one imaging session on a 3T MR scanner prior to treatment.
DKI data are quantitively analyzed in order to estimate specific parameters in normal appearing white matter, grey matter, tumor and peritumoral edema. MRS data are analyzed quantitatively and qualitatively with peak integration, ratio calculation and classification algorithms. Histological confirmation is obtained at subsequent surgery.
Information from this study can be of significant importance in avoiding brain biopsies. Furthermore, information on microscopic tumour spread can be used during neurosurgery or in radiotherapy planning. An important advantage of these advanced MR techniques is the non-invasivity and the lack of ionizing radiation, two important issues in this relatively young patient population.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with a gliomatuous brain tumor, prior to treatment
Key inclusion criteria (1 listed)
- diagnosis of gliomatous brain tumour
Key exclusion criteria (3 listed)
- younger than 18 years of age
- prior treatment
- history of neurological or neurosurgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 29 Sep 2011.
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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.
Stefan Sunaert, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Uwe Himmelreich, PhD principal investigator
Catholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gliomas, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 3 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 29 Sep 2011. 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 Belgium. 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.
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 29 Sep 2011.