Ultrasonography Guided Brain Lesions Resection:

Ultrasonography Guided Brain Lesions Resection: a Tool for a Real Time Intraoperative Neuronavigation

1. Evaluate the clinical value of intraoperative ultrasonography as a real-time guidance
2. Combination of data of MRI Tractography and intra operative ultrasonography will be useful in good localization of lesions or not .
3. Maximal safe resection .

Study Overview

• Status: Unknown
• Conditions: Patients Who Are Diagnosed to Have Intracranial Lesions
• Intervention / Treatment: Device: use of intraoperative ultrasound

Detailed Description

Accurate pre and intraoperative localization of Brain lesions is a challenge in neurosurgery specially deep intra cerebral lesions. Stereotaxy and neuronavigator played a major role in preoperative and intraoperative evaluation of exact location of intra cerebral lesions, the main drawbacks of using steriotaxy and neuronavigator that they are time consuming, complicated and expensive.(1) Nowadays we use MRI Tractography as preoperative imaging to localize lesions and there relation to neural tracts specially in eloquent brain areas, and also intraoperative ultrasonography Which act as a real-time, unexpansive and relatively simple tool for intraoperative visualization of the lesion's location, size, extent and its relationship with the surrounding tissue, also it can reveal the lesion's blood supply, it can measure the rate and direction of arterial blood flow.(2,3,4) Intraoperative ultrasonic imaging was first applied as a real-time navigation system in neurosurgery in 1980. (5) In this research we will combine the use of preoperative MRI tractography with intra operative ultrasonography in accurate localization of brain lesions and its relation with important tracts and if this combination will be beneficial and add to the safety of excision of lesions or not.

• Study Type: Observational
• Enrollment (Anticipated): 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients diagnosed to have brain lesion, selected based on the inclusion and exclusion criteria

Description

Inclusion Criteria:

• Patients who are diagnosed to have Intracranial lesions Patients with recurrent lesions

Exclusion Criteria:

• Patients who are unfit for surgery Patients who have multifocal lesions

Study Plan

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
Extent of resection of the lesion	Extent of resection of the lesion evaluated by comparing pre operative and post operative MRI	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative complication	post operative complication evaluated by full neurological examination	one month

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Radwan nouby mahmoud, prof, assuit nuiversity hospital neurosurgery department; Study Director: wael mohamed ali, prof, assuit nuiversity hospital neurosurgery department; Study Director: mohamed aly ragaee, prof, assuit nuiversity hospital neurosurgery department

Publications and helpful links

Helpful Links

• related info
• related info

Study record dates

Study Major Dates

• Study Start (Anticipated): September 25, 2020
• Primary Completion (Anticipated): July 25, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: intra operative ultrasound

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No