Patients Who Are Diagnosed to Have Intracranial LesionsNCT04569526
Ultrasonography Guided Brain Lesions Resection:
An observational study of Patients Who Are Diagnosed to Have Intracranial Lesions, run by Assiut University.
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 . Read more about this study
- Who is it for?
- Ages 1 month to 70 years
- Conditions the study is for
- Patients Who Are Diagnosed to Have Intracranial Lesions
- What is being tested?
- use of intraoperative ultrasound
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2020to 30 Dec 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed to have brain lesion, selected based on the inclusion and exclusion criteria
Who may be able to join
- Patients who are diagnosed to have Intracranial lesions Patients with recurrent lesions
Who cannot join
- Patients who are unfit for surgery Patients who have multifocal lesions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasonography Guided Brain Lesions Resection: a Tool for a Real Time Intraoperative Neuronavigation
- Evaluate the clinical value of intraoperative ultrasonography as a real-time guidance
- Combination of data of MRI Tractography and intra operative ultrasonography will be useful in good localization of lesions or not .
- Maximal safe resection .
Read the 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.
- Being tested
- use of intraoperative ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of intraoperative ultrasoundDevice
Ultrasonography guided brain lesions resection intra operatively for good localization
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of resection of the lesion
Extent of resection of the lesion evaluated by comparing pre operative and post operative MRI
Measured: 48 hours
Secondary outcomes (1)
post operative complication
post operative complication evaluated by full neurological examination
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start25 Sep 2020 (estimated)
- Primary completion25 Jul 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Are Diagnosed to Have Intracranial LesionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Ahmed Saad, Assiut University
- Investigators
- Radwan nouby mahmoud, prof, Study director, assuit nuiversity hospital neurosurgery departmentwael mohamed ali, prof, Study director, assuit nuiversity hospital neurosurgery departmentmohamed aly ragaee, prof, Study director, assuit nuiversity hospital neurosurgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569526
- Sponsor's protocol ID
- intra operative ultrasound
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Guided Brain Lesions Resection: a Tool for a Real Time Intraoperative Neuronavigation
- ClinicalTrials.gov ID
- NCT04569526
- Acronym / sponsor ID
- intra operative ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Sep 2020 (estimated)
- Primary completion
- 25 Jul 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Evaluate the clinical value of intraoperative ultrasonography as a real-time guidance
- Combination of data of MRI Tractography and intra operative ultrasonography will be useful in good localization of lesions or not .
- Maximal safe resection .
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 1 month to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed to have brain lesion, selected based on the inclusion and exclusion criteria
Key inclusion criteria (1 listed)
- Patients who are diagnosed to have Intracranial lesions Patients with recurrent lesions
Key exclusion criteria (1 listed)
- Patients who are unfit for surgery Patients who have multifocal lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of intraoperative ultrasoundUltrasonography guided brain lesions resection intra operatively for good localization | Device | – |
Primary outcome
Extent of resection of the lesion
Time frame: 48 hours
Extent of resection of the lesion evaluated by comparing pre operative and post operative MRI
1 secondary outcome
post operative complication
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- related infoLink provided by the sponsor.
- related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radwan nouby mahmoud, prof study director
assuit nuiversity hospital neurosurgery department
wael mohamed ali, prof study director
assuit nuiversity hospital neurosurgery department
mohamed aly ragaee, prof study director
assuit nuiversity hospital neurosurgery department
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Who Are Diagnosed to Have Intracranial Lesions, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sarah ahmed saad tawfik, Rdr (01099842575 ext. 002, sarahahmedsaad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of resection of the lesion (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.