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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04569526
Other study ID # intra operative ultrasound
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 25, 2020
Est. completion date December 30, 2021

Study information

Verified date September 2020
Source Assiut University
Contact sarah ahmed saad tawfik, Rdr
Phone 01099842575
Email sarahahmedsaad@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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 .


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date December 30, 2021
Est. primary completion date July 25, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Month to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Patients Who Are Diagnosed to Have Intracranial Lesions

Intervention

Device:
use of intraoperative ultrasound
Ultrasonography guided brain lesions resection intra operatively for good localization

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Extent of resection of the lesion Extent of resection of the lesion evaluated by comparing pre operative and post operative MRI 48 hours
Secondary post operative complication post operative complication evaluated by full neurological examination one month

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