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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05873946
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hospital del Rio Hortega
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Santiago Cepeda, MD.,PhD.
Principal Investigator Affiliation Department of Neurosurgery, Río Hortega University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma, Glioma, Malignant, Low-grade Glioma, High-grade Glioma, Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

: Operated gliomas

Patients consecutively operated with a pathological diagnosis of glial tumor

Interventions

Diagnostic Test: - intraoperative ultrasound

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital Rio Hortega, Valladolid, Spain

Status

Address

University Hospital Rio Hortega

Valladolid, , 47012

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