- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05565690
Role of MRS in Brain Lesions
September 30, 2022 updated by: Ahmed Mohamed Aboelmagd Ahmed, Assiut University
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed Mohamed Aboelmagd, Resident doctor
- Phone Number: 01099474580
- Email: ahmed.14223789@med.aun.edu.eg
Study Contact Backup
- Name: Mohamed El-Sayed Mahmoud, Professor
- Phone Number: 01016077797
- Email: msmluxor@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with brain lesions of any age
Description
Inclusion Criteria:
- patients with solitary intraaxial brain lesions
- patients with de novo lesions
- Patient age : any age
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ali Ahmed Abd-Elaleem, Lecturer, Assiut University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2022
Primary Completion (Anticipated)
October 1, 2024
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
September 30, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (Actual)
October 4, 2022
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
September 30, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- MRS in brain lesions
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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