Glioma2D-ioUS-GlioNCT05873946
Assessing the Effectiveness of 2D Non-Navigated Intraoperative Ultrasound in Glioma Surgery
An observational study of Glioma and Glioma, Malignant, run by Hospital del Rio Hortega at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma, Glioma, Malignant, Low-grade Glioma
- What is being tested?
- intraoperative ultrasound
- How many people
- 99 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Glioma, Glioma, Malignant, Low-grade Glioma, High-grade Glioma, Glioblastoma
- Being tested
- intraoperative ultrasound
- Keywords
- Glioma, Low-grade glioma, High-grade glioma, intraoperative ultrasound, extent of resection
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative ultrasoundDiagnostic test
Use of 2D non-navigated intraoperative ultrasound as an operative adjunct
| Study group | Role | What they receive |
|---|---|---|
| Operated gliomas | Patients consecutively operated with a pathological diagnosis of glial tumor Receives: Diagnostic Test: intraoperative ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of tumor resection
Percentage of tumor removal
Measured: 24 hours after the surgery
Secondary outcomes (1)
Postoperative neurological deficit
Neurological deficit after the surgery determined by physical examination
Measured: From 24 hours to 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jun 2018
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Cepeda, Hospital del Rio Hortega
- Investigators
- Santiago Cepeda, MD.,PhD., Principal investigator, Department of Neurosurgery, Río Hortega University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873946
- Sponsor's protocol ID
- 21-PI085-B
- Acronym
- 2D-ioUS-Glio
- Status last verified
- Sep 2023
- First submitted
- 16 May 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38413458
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of 2D Non-Navigated Intraoperative Ultrasound on Extent of Resection and Patients' Outcome in Glioma Surgery: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05873946
- Acronym / sponsor ID
- 2D-ioUS-Glio / 21-PI085-B
- Conditions
- Glioma, Glioma, Malignant, Low-grade Glioma, High-grade Glioma, Glioblastoma
- Keywords
- Glioma, Low-grade glioma, High-grade glioma, intraoperative ultrasound, extent of resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operated gliomas | – | Diagnostic Test: intraoperative ultrasoundPatients consecutively operated with a pathological diagnosis of glial tumor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative ultrasoundUse of 2D non-navigated intraoperative ultrasound as an operative adjunct | Diagnostic test | Operated gliomas |
Primary outcome
Extent of tumor resection
Time frame: 24 hours after the surgery
Percentage of tumor removal
1 secondary outcome
Postoperative neurological deficit
Time frame: From 24 hours to 30 days after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 38413458Cepeda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Cepeda, MD.,PhD. principal investigator
Department of Neurosurgery, Río Hortega University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma and Glioma, Malignant, run by Hospital del Rio Hortega at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of tumor resection (time frame: 24 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05873946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.