Diffusion-tensor Imaging in Brain Tumors Evaluation

February 20, 2022 updated by: Mihail Porutiu, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

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

Study Locations

  • Romania
    • Mures
      • Targu Mures, Mures, Romania, 540136

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected primary or secondary brain tumors, confirmed by routine MRI evaluation followed by surgical treatment and histopathological exam.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with primary brain tumors
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.
Patients with secondary brain tumors
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tract damage
Time Frame: 3 months
Assess the damage of tracts at baseline preoperative
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Craniotomy size
Time Frame: 3 months
Assess the size of craniotomy in patients with postoperative CT follow-up
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

Investigators

  • Principal Investigator: Mihail Porutiu, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

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 (Actual)

February 15, 2021

Primary Completion (Actual)

March 14, 2021

Study Completion (Anticipated)

March 14, 2022

Study Registration Dates

First Submitted

February 20, 2022

First Submitted That Met QC Criteria

February 20, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 20, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEPaladeU

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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