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NCT05261724 Clinical Trial

Diffusion-tensor Imaging in Brain Tumors Evaluation

MRI Clinical Trial

Official title:
Contribution of Diffusion Tensor Imaging and Tractography in Primary and Secondary Brain Tumors Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05261724
Other study ID # GEPaladeU
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2021
Est. completion date March 14, 2022

Study information
Verified date February 2022
Source George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Contact Mihail Porutiu
Phone +40722694996
Email mihai.nobel@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Primary and secondary brain tumors are challenging pathologies regarding diagnosis and treatment. MRI is widely used in the imaging evaluation and surgical planning, due to its spatial resolution and ability of tissular characterization. In this study patients with suspected brain tumors, confirmed by routine MRI evaluation (T1, T2, T2*, FLAIR, T1 with contrast sequences) will undergo DWI and DTI evaluation. By analyzing collected data from MRI evaluation and patient records regarding surgical and histopathological data our aim is to investigate derived imaging biomarkers with impact in the surgical planning and rehabilitation of the patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 14, 2022
Est. primary completion date March 14, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - brain tumors confirmed by routine MRI evaluation - surgical treatment with histopathological diagnosis Exclusion Criteria: - MRI contraindications - past or present neurological or neurosurgical condition, beside the tumor - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MRI
In this study patients with suspected primary and secondary brain tumors, confirmed by routine MRI evaluation (T1, T2, T2*, FLAIR, T1 with contrast sequences) will undergo DWI and DTI evaluation.

Locations
Country Name City State
Romania SCJU Mures Targu Mures Mures

Sponsors (1)
Lead Sponsor Collaborator
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tract damage Assess the damage of tracts at baseline preoperative 3 months
Secondary Craniotomy size Assess the size of craniotomy in patients with postoperative CT follow-up 3 months
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