NCT05873946

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2018

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

5.1 years

First QC Date

May 16, 2023

Last Update Submit

September 24, 2023

Conditions

GliomaGlioma, MalignantLow-grade GliomaHigh-grade GliomaGlioblastoma

Keywords

GliomaLow-grade gliomaHigh-grade gliomaintraoperative ultrasoundextent of resection

Outcome Measures

Primary Outcomes (1)

  • Extent of tumor resection

    Percentage of tumor removal

    24 hours after the surgery

Secondary Outcomes (1)

  • Postoperative neurological deficit

    From 24 hours to 30 days after the surgery

Study Arms (1)

Operated gliomas

Patients consecutively operated with a pathological diagnosis of glial tumor

Diagnostic Test: intraoperative ultrasound

Interventions

intraoperative ultrasoundDIAGNOSTIC_TEST

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

Operated gliomas

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Rio Hortega

Valladolid, 47012, Spain

Location

Related Publications (1)

  • Cepeda S, Garcia-Garcia S, Arrese I, Sarabia R. Non-navigated 2D intraoperative ultrasound: An unsophisticated surgical tool to achieve high standards of care in glioma surgery. J Neurooncol. 2024 May;167(3):387-396. doi: 10.1007/s11060-024-04614-5. Epub 2024 Feb 28.

    PMID: 38413458DERIVED

MeSH Terms

Conditions

GliomaGlioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Santiago Cepeda, MD.,PhD.

    Department of Neurosurgery, Río Hortega University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 24, 2023

Study Start

June 1, 2018

Primary Completion

June 30, 2023

Study Completion

July 30, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)