NCT05707728

Brief Summary

The use of intraoperative ultrasound (IOUS )seems to have significantly increased the Gross total Resection rate achieved in brain gliomas surgery. As regard intraoperative visualisation of the tumor and its residuals, the effectiveness of IOUS has been documented in a series of 192 High Grade glioma patients, in which the combination of neuronavigation and IOUS was also related to increased overall survival in a prospective study of 32 patients, documented a good level of agreement between intraoperative ultrasonography and postoperative contrast-enhanced MRI in detecting tumor residuel they concluded that the IOUS produces results similar to those of MRI, and therefore, can be used to maximize tumor resection.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

January 21, 2023

Last Update Submit

February 3, 2023

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

  • Numbers of patients who have gliomas and totally resection by using intraoperative ultrasound

    Numbers of patients who have gliomas and totally resection by using intraoperative ultrasound

    1 year

Study Arms (1)

totally resection of glioma using intraoperative ultrasound

totally resection of glioma using intraoperative ultrasound

Device: intraoperative ultrasound

Interventions

intraoperative ultrasoundDEVICE

intraoperative cranial ultrasound

totally resection of glioma using intraoperative ultrasound

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with all grades of gliomas confirmed by MRI any age and any sex

You may qualify if:

  • Patients with all grades of gliomas confirmed by MRI , MRI with contrast and MR spectroscopy .
  • Age of the patient: any age.
  • Both sex

You may not qualify if:

  • Other tumours and space occupying lesion (sol) rather than gliomas confirmed by histopathology and preoperative imaging
  • Patients unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1. Giammalva, G.R.; Iacopino, D.G.; Azzarello, G.; Gaggiotti, C.; Graziano, F.; Gulì, C.; Pino, M.; Maugeri, R. End-of-Life Care in High-Grade Glioma Patients. The Palliative and Supportive Perspective. Brain Sci. 2018, 8, 125. [CrossRef] [PubMed] 2. La Torre, D.; Maugeri, R.; Angileri, F.F.; Pezzino, G.; Conti, A.; Cardali, S.M.; Calisto, A.; Sciarrone, G.; Misefari, A.; Germanò, A.; et al. Human leukocyte antigen frequency in human high-grade gliomas: A case-control study in Sicily. Neurosurgery 2009, 64, 1082-1088. [CrossRef] [PubMed] 3. Maugeri, R.; Schiera, G.; Di Liegro, C.M.; Fricano, A.; Iacopino, D.G.; Di Liegro, I. Aquaporins and brain tumors. Int. J. Mol. Sci. 2016, 17, 1029. [CrossRef] [PubMed] 4. Grasso, G.; Meli, F.; Fodale, V.; Calapai, G.; Buemi, M.; Iacopino, D.G. Neuroprotective potential of erythropoietin and darbepoetin alfa in an experimental model of sciatic nerve injury. J. Neurosurg. Spine 2007, 7, 645-651. [CrossRef] [PubMed] 5. Unsgaard G, Ommendal S, Muller T, Gronningsaeter A, Hernes TAN. Neuronavigation by intraoperative three-dimensional ultrasound: initial experience during brain tumor resection. Neurosurgery. 2002;50(4): 804-12. 6. Almenawer SA, Badhiwala JH, Alhazzani W, Greenspoon J, Farrokhyar F, Yarascavitch B, et al. Biopsy versus partial versus gross total resection in older patients with high-grade glioma: a systematic review and metaanalysis. Neuro Oncol. 2015;17(6):868-81. 7. Elserry TH, Anwer H, Radwan HA. Introduction of vaginal probe for intraoperative ultrasound of intra-axial brain lesions. Egyp J Neurosurg. 2013; 28(4):5-12. 8. Zhang ZZ, Shield LBE, Sun DA, Zhang YP, Hunt MA, Christopher BS. The art of intraoperative glioma identification. Front Oncol. 2015;5(175):1-7. 9. Gronningsaeter A, Kleven A, Ommedal S, Aarseth TE, Lie T, Lindseth F, Lango T, Unsgaar

    BACKGROUND

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Fadwa Ahmed Ahmed, resident

CONTACT

0201002673946Fadwa.ahmed5@gmail.com

shady abdelrahem hassan, Assistant professor

CONTACT

0201144344998Shadyhassaan86@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

January 21, 2023

First Posted

February 1, 2023

Study Start

March 1, 2023

Primary Completion

April 1, 2024

Study Completion

October 1, 2024

Last Updated

February 8, 2023

Record last verified: 2023-01