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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05565690
Other study ID # MRS in brain lesions
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date November 1, 2024

Study information

Verified date September 2022
Source Assiut University
Contact Ahmed Mohamed Aboelmagd, Resident doctor
Phone 01099474580
Email ahmed.14223789@med.aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 64
Est. completion date November 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
MRS
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline
See also
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Recruiting NCT06314607 - Genetic and Molecular Characterization of Nervous System Lesions