2D-ioUS-Glio: Assessing the Effectiveness of 2D Non-Navigated Intraoperative Ultrasound in Glioma Surgery

Sponsor

Hospital del Río Hortega (Other)

Overall Status

Recruiting

CT.gov ID

NCT05873946

Collaborator

(none)

100

Enrollment

Location

61.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This retrospective study aims to assess the utility of 2D non-navigated intraoperative ultrasound (ioUS) as a cost-effective alternative for guiding the surgical resection of gliomas and for detecting residual tumor. The study will analyse the records from consecutive adult patients diagnosed with gliomas, undergoing craniotomy between June 2018 and June 2023. The extent of resection (EOR) will be determined using postoperative MRI as the gold standard. The study will also examine the sensitivity and specificity of ioUS in detecting residual tumor. This research seeks to determine if ioUS can be an affordable and reliable tool that, combined with other intraoperative adjuncts, may aid neurosurgeons in achieving the maximum safe resection in glioma surgery.

Condition or Disease	Intervention/Treatment	Phase
Glioma Glioma, Malignant Low-grade Glioma High-grade Glioma Glioblastoma	Diagnostic Test: intraoperative ultrasound

Detailed Description

Objective:

The objective of this retrospective study is to evaluate the effectiveness and utility of 2D non-navigated intraoperative ultrasound (ioUS) as a cost-effective method for guiding the surgical resection of gliomas and detecting residual tumor.

Methods:

The study will retrospectively analyze the records of consecutive adult patients diagnosed with gliomas who underwent craniotomy between June 2018 and June 2023. The patients' records must show that they underwent both intraoperative ultrasound and postoperative MRI.

Evaluation Criteria:

The primary evaluation metric will be the extent of resection (EOR), which will be determined using postoperative MRI scans as the gold standard. The EOR will be classified into gross total resection (GTR), near-total resection (NTR), subtotal resection (STR), and partial resection (PR) based on the MRI scans.

The study will also examine the sensitivity and specificity of ioUS in detecting residual tumor postoperatively. This analysis will help determine the accuracy of ioUS in predicting residual tumor that may not have been apparent during the surgical procedure.

Expected Outcomes:

The study aims to determine if ioUS can be a reliable and affordable tool for guiding the surgical resection of gliomas. If successful, ioUS, in conjunction with other intraoperative adjuncts, may provide a cost-effective method to aid neurosurgeons in achieving the maximum safe resection in glioma surgery.

The results of this study could have significant implications for the management of glioma patients, potentially leading to improved surgical outcomes, decreased postoperative complications, and ultimately, improved patient survival and quality of life.

The data collected from this retrospective analysis could also provide valuable insights for future prospective studies and could contribute to the development of guidelines for the use of ioUS in neurosurgery.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Evaluating the Impact of 2D Non-Navigated Intraoperative Ultrasound on Extent of Resection and Patients' Outcome in Glioma Surgery: A Retrospective Study

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Operated gliomas Patients consecutively operated with a pathological diagnosis of glial tumor	Diagnostic Test: intraoperative ultrasound Use of 2D non-navigated intraoperative ultrasound as an operative adjunct

Arm

Intervention/Treatment

Operated gliomas

Patients consecutively operated with a pathological diagnosis of glial tumor

Diagnostic Test: intraoperative ultrasound

Use of 2D non-navigated intraoperative ultrasound as an operative adjunct

Outcome Measures

Primary Outcome Measures

Extent of tumor resection [24 hours after the surgery]
Percentage of tumor removal

Secondary Outcome Measures

Postoperative neurological deficit [From 24 hours to 30 days after the surgery]
Neurological deficit after the surgery determined by physical examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Adult patients aged 18 years or older.
Patients diagnosed with gliomas, confirmed by a pathologist.
Patients who are scheduled to undergo craniotomy for tumor resection.
Patients who are willing and able to give informed consent for participation in the trial.
Patients who are capable of undergoing both intraoperative ultrasound and postoperative MRI.

Exclusion Criteria:

Patients under the age of 18.
Patients with non-glioma brain tumors.
Patients who underwent stereotactic biopsies.
Patients who are unable to provide informed consent due to cognitive impairment, language barriers, or any other reason.
Patients with contraindications for MRI such as certain types of implanted medical devices, severe claustrophobia, or allergies to contrast material.
Pregnant or breastfeeding women.