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

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

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.

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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