Brain Lesion (General)NCT05565690
Role of MRS in Brain Lesions
An observational study of Brain Lesion (General) and Mrs, run by Assiut University.
Trial summary
Aim of the study is evaluation of accuracy of magnetic resonance spectroscopy in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Lesion (General), Mrs
- What is being tested?
- MRS
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Nov 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with brain lesions of any age
Who may be able to join
- patients with solitary intraaxial brain lesions
- patients with de novo lesions
- Patient age : any age
Who cannot join
- patients with multiple intra-axial brain lesions
- patients with extra-axial brain lesions
- patients with recurrent lesions
- patients receiving chemotherapy or radiotherapy
- patients unfit for surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Yield of Preoperative Magnetic Resonance Spectroscopy for Solitary Intra-axial Brain Lesion in Comparison to Histopathology
Aim of the study is evaluation of accuracy of magnetic resonance spectroscopy in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm
Read the detailed description
The annual global age-standardized incidence of primary malignant brain tumors is ~3.7 per 100,000 for males and 2.6 per 100,000 for females . Rates appear to be higher more in developed countries (males, 5.8 and females, 4.1 per 100,000) than in less developed countries (males 3.0 and females 2.1 per 100,000). More than half of all brain tumors are Intraparenchymal . Diagnosis of brain lesions and other focal intracranial lesions based on imaging methods alone is still facing a challenging problem. Accurate diagnosis is fundamentally vital for clinical management in patients with brain tumors. CT and standard MRI are the first line imaging modalities in evaluation of brain lesions; however, it does not always provide more precise details and characterization of the lesions whether it is benign or malignant. Conventional imaging techniques do not provide exact information about vascularity, cellularity and metabolism of the mass lesion . Magnetic Resonance Spectroscopy (MR Spectroscopy) is one of the tools used to determine themolecular structures of compounds or to detect the compound presence. MR Spectroscopy provides metabolic information from living tissues. The major brain metabolites detected are choline, creatine, N-acetyl aspartate (NAA), lactate, myoinositol, glutamine, glutamate, lipids and the amino acids leucine and alanine. Brain lesions show abnormal values of these metabolites as compared to normal tissue.Our study aims to determine the accuracy of MRS in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm, Discriminating neoplastic from non-neoplastic brain lesions is extremely necessary since a misdiagnosis can lead to a severe effect on neurosurgery and exposure to toxic chemotherapy or radiotherapy, which may cause damage to brain tissues.
- Conditions
- Brain Lesion (General), Mrs
- Being tested
- MRS
- Medical subject headings
- Melkersson-Rosenthal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRSDevice
It is a tool used to determine the molecular structure of compounds or to detect the compound presence , it provides metabolic information from living brain
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of accuracy of magnetic resonance spectroscopy in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm
Analysis of the MRS metabolites peaks and test if they can differentiate between neoplastic and non neoplastic lesions and grades of neoplasm by comparison with postoperative histopathology
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Lesion (General)Studies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Aboelmagd Ahmed, Assiut University
- Investigators
- Ali Ahmed Abd-Elaleem, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565690
- Sponsor's protocol ID
- MRS in brain lesions
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield of Preoperative Magnetic Resonance Spectroscopy for Solitary Intra-axial Brain Lesion in Comparison to Histopathology
- ClinicalTrials.gov ID
- NCT05565690
- Acronym / sponsor ID
- MRS in brain lesions
- Conditions
- Brain Lesion (General), Mrs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 4 Oct 2022 (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.
Aim of the study is evaluation of accuracy of magnetic resonance spectroscopy in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm
Detailed description
The annual global age-standardized incidence of primary malignant brain tumors is ~3.7 per 100,000 for males and 2.6 per 100,000 for females . Rates appear to be higher more in developed countries (males, 5.8 and females, 4.1 per 100,000) than in less developed countries (males 3.0 and females 2.1 per 100,000). More than half of all brain tumors are Intraparenchymal . Diagnosis of brain lesions and other focal intracranial lesions based on imaging methods alone is still facing a challenging problem. Accurate diagnosis is fundamentally vital for clinical management in patients with brain tumors. CT and standard MRI are the first line imaging modalities in evaluation of brain lesions; however, it does not always provide more precise details and characterization of the lesions whether it is benign or malignant. Conventional imaging techniques do not provide exact information about vascularity, cellularity and metabolism of the mass lesion . Magnetic Resonance Spectroscopy (MR Spectroscopy) is one of the tools used to determine themolecular structures of compounds or to detect the compound presence. MR Spectroscopy provides metabolic information from living tissues. The major brain metabolites detected are choline, creatine, N-acetyl aspartate (NAA), lactate, myoinositol, glutamine, glutamate, lipids and the amino acids leucine and alanine. Brain lesions show abnormal values of these metabolites as compared to normal tissue.Our study aims to determine the accuracy of MRS in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm, Discriminating neoplastic from non-neoplastic brain lesions is extremely necessary since a misdiagnosis can lead to a severe effect on neurosurgery and exposure to toxic chemotherapy or radiotherapy, which may cause damage to brain tissues.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with brain lesions of any age
Key inclusion criteria (3 listed)
- patients with solitary intraaxial brain lesions
- patients with de novo lesions
- Patient age : any age
Key exclusion criteria (5 listed)
- patients with multiple intra-axial brain lesions
- patients with extra-axial brain lesions
- patients with recurrent lesions
- patients receiving chemotherapy or radiotherapy
- patients unfit for surgery
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 |
|---|---|---|
| MRSIt is a tool used to determine the molecular structure of compounds or to detect the compound presence , it provides metabolic information from living brain | Device | – |
Primary outcome
evaluation of accuracy of magnetic resonance spectroscopy in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm
Time frame: Baseline
Analysis of the MRS metabolites peaks and test if they can differentiate between neoplastic and non neoplastic lesions and grades of neoplasm by comparison with postoperative histopathology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
Related trials for Brain Lesion (General)
Recruiting
Closed-loop rTMS-EEG During Visuomotor Integration.
Visuomotor Skills, Brain Lesion (General)
RecruitingObservational study
Genetic and Molecular Characterization of Nervous System Lesions
Brain Tumor, Brain Lesion (General)
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.
Ali Ahmed Abd-Elaleem, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Lesion (General) and Mrs, run by Assiut University.
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 3 inclusion and 5 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Mohamed Aboelmagd, Resident doctor (01099474580, ahmed.14223789@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of accuracy of magnetic resonance spectroscopy in differentiation between neoplastic and non neoplastic lesions and determination the type of neoplasm (time frame: 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 4 Oct 2022.