Brain NeoplasmsNCT03619694
Role of MR Spectroscopy in Brain Tumors
An observational study of Brain Neoplasms, run by Assiut University at 1 site in Egypt.
Trial summary
In order to come as close as possible to the correct diagnosis of CNS tumors, MRI is the long-standing accepted method of choice that can in some cases be supported by the use of CT to demonstrate calcification or bone destruction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- MRI Spectroscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Oct 2018
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with brain tumors diagnosed by conventional imaging
Who may be able to join
- All patients with space-occupying lesions
Who cannot join
- Post operative cases
- Non-neoplastic nature
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Magnetic Resonance Spectroscopy in Differentiating Brain Tumors
In order to come as close as possible to the correct diagnosis of CNS tumors, MRI is the long-standing accepted method of choice that can in some cases be supported by the use of CT to demonstrate calcification or bone destruction. In individual cases MRI spectroscopy can be helpful for the differentiation between neoplasms and inflammatory lesions or surveillance of tumor therapy, just as perfusion
Read the detailed description
Proton magnetic resonance spectroscopy (H-MRS) may be helpful in suggesting tumor histology and tumor grade and may better define tumor extension and the ideal site for biopsy compared with conventional magnetic resonance (MR) imaging. A multifunctional approach with diffusion-weighted imaging, perfusion-weighted imaging, and permeability maps, along with H-MRS, may enhance the accuracy of the diagnosis and characterization of brain tumors and estimation of therapeutic response. Integration of advanced imaging techniques with conventional MR imaging and the clinical history help to improve the accuracy, sensitivity, and specificity in differentiating tumors and nonneoplastic lesions.
- Conditions
- Brain Neoplasms
- Being tested
- MRI Spectroscopy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI SpectroscopyDevice
Patient with brain SOL underwent MRI Spectroscopy to be compared with later pathology
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of MRS findings with the pathology of the specimens
Analysis of the MRS metabolites peaks and integral and test if they can differentiate the grades of brain tumors
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Sep 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelwahab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619694
- Sponsor's protocol ID
- MRS in brain tumors
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peitgen N, Papanagiotou P. [Intra-axial brain tumors in adults : On the basis of the 2016 WHO classification]. Radiologe. 2017 Sep;57(9):707-714. doi: 10.1007/s00117-017-0271-6. German.
PubMed 28667395Brindle KM, Izquierdo-Garcia JL, Lewis DY, Mair RJ, Wright AJ. Brain Tumor Imaging. J Clin Oncol. 2017 Jul 20;35(21):2432-2438. doi: 10.1200/JCO.2017.72.7636. Epub 2017 Jun 22.
PubMed 28640699
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Magnetic Resonance Spectroscopy in Differentiating Brain Tumors
- ClinicalTrials.gov ID
- NCT03619694
- Acronym / sponsor ID
- MRS in brain tumors
- Conditions
- Brain Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 8 Aug 2018 (actual)
- 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 order to come as close as possible to the correct diagnosis of CNS tumors, MRI is the long-standing accepted method of choice that can in some cases be supported by the use of CT to demonstrate calcification or bone destruction. In individual cases MRI spectroscopy can be helpful for the differentiation between neoplasms and inflammatory lesions or surveillance of tumor therapy, just as perfusion
Detailed description
Proton magnetic resonance spectroscopy (H-MRS) may be helpful in suggesting tumor histology and tumor grade and may better define tumor extension and the ideal site for biopsy compared with conventional magnetic resonance (MR) imaging. A multifunctional approach with diffusion-weighted imaging, perfusion-weighted imaging, and permeability maps, along with H-MRS, may enhance the accuracy of the diagnosis and characterization of brain tumors and estimation of therapeutic response. Integration of advanced imaging techniques with conventional MR imaging and the clinical history help to improve the accuracy, sensitivity, and specificity in differentiating tumors and nonneoplastic lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with brain tumors diagnosed by conventional imaging
Key inclusion criteria (1 listed)
- All patients with space-occupying lesions
Key exclusion criteria (2 listed)
- Post operative cases
- Non-neoplastic nature
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 SpectroscopyPatient with brain SOL underwent MRI Spectroscopy to be compared with later pathology | Device | – |
Primary outcome
Comparison of MRS findings with the pathology of the specimens
Time frame: Baseline
Analysis of the MRS metabolites peaks and integral and test if they can differentiate the grades of brain tumors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 28667395Peitgen N, Papanagiotou P. [Intra-axial brain tumors in adults : On the basis of the 2016 WHO classification]. Radiologe. 2017 Sep;57(9):707-714. doi: 10.1007/s00117-017-0271-6. German.
- Background: PubMed 28640699Brindle KM, Izquierdo-Garcia JL, Lewis DY, Mair RJ, Wright AJ. Brain Tumor Imaging. J Clin Oncol. 2017 Jul 20;35(21):2432-2438. doi: 10.1200/JCO.2017.72.7636. Epub 2017 Jun 22.
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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.
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 Brain Neoplasms, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 2018. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed AbdelWahab, Msc (01148918822 ext. +20, dr.assiut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of MRS findings with the pathology of the specimens (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619694, which also lists 2 linked publications.
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 8 Aug 2018.