Skip to main content
OpenTrials
Completed

NCT Number: NCT05873946

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Rio Hortega

Valladolid, 47012, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraoperative ultrasound

Diagnostic Test

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

Primary outcomes

  1. Extent of tumor resection

    Time frame: 24 hours after the surgery

    Percentage of tumor removal

Secondary outcomes

  1. Postoperative neurological deficit

    Time frame: From 24 hours to 30 days after the surgery

    Neurological deficit after the surgery determined by physical examination

Sponsors and collaborators

Lead sponsor

Hospital del Rio Hortega

Other

Registry information

Official study title

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

Acronym: 2D-ioUS-Glio

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.