Glioblastoma Clinical Trial
— 2D-ioUS-GlioOfficial title:
Evaluating the Impact of 2D Non-Navigated Intraoperative Ultrasound on Extent of Resection and Patients' Outcome in Glioma Surgery: A Retrospective Study
NCT number | NCT05873946 |
Other study ID # | 21-PI085-B |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | July 30, 2023 |
Verified date | September 2023 |
Source | Hospital del Río Hortega |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | July 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | University Hospital Rio Hortega | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Hospital del Río Hortega |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Extent of tumor resection | Percentage of tumor removal | 24 hours after the surgery | |
Secondary | Postoperative neurological deficit | Neurological deficit after the surgery determined by physical examination | From 24 hours to 30 days after the surgery |
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