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

September 24, 2023 updated by: Santiago Cepeda, Hospital del Río Hortega

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valladolid, Spain, 47012
        • University Hospital Río Hortega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population for this clinical trial will comprise of adult patients aged 18 years or older who have been diagnosed with gliomas. The population will likely reflect a diverse range of glioma types and stages, providing a comprehensive assessment of the effectiveness of the 2D non-navigated intraoperative ultrasound in the surgical management of these tumors.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of tumor resection
Time Frame: 24 hours after the surgery
Percentage of tumor removal
24 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative neurological deficit
Time Frame: From 24 hours to 30 days after the surgery
Neurological deficit after the surgery determined by physical examination
From 24 hours to 30 days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Río Hortega

Investigators

  • Principal Investigator: Santiago Cepeda, MD.,PhD., Department of Neurosurgery, Río Hortega University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-PI085-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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