Supramarginal Resection in Glioblastoma Guided by Artificial Intelligence

Glioblastoma Clinical Trial

— SupraGlio-AI  

Official title:

Tailored Supramarginal Resection in Glioblastoma Guided by Artificial Intelligence-based Recurrence Probability Maps. A Non-randomized Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735171
• Other study ID #: 22-PI208
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: Hospital del Río Hortega
• Contact: Santiago Cepeda, PhD
• Phone: +34983420400
• Email: scepedac[@]saludcastillayleon.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Glioblastomas are the most common and poorly prognostic primary brain neoplasms. Despite advances in surgical techniques and chemotherapy, the median survival time for these patients remains less than 15 months. This highlights the need for more effective treatments and improved prognostic tools. The globally accepted surgical strategy currently consists of achieving the maximum safe resection of the enhancing tumor volume. However, the non-enhancing peritumoral region contains viable cells that cause the inevitable recurrence that these patients face. Clinicians currently lack an imaging tool or modality to differentiate neoplastic infiltration in the peritumoral region from vasogenic edema. In addition, it is not always feasible to include all the T2-FLAIR signal alterations surrounding the enhancing tumor in the surgical planning due to the proximity of eloquent areas and the higher risk of postoperative deficits.

However, the investigators have developed a model to predict regions of recurrence based on machine learning and MRI radiomic features that have been trained and evaluated in a multi-institutional cohort.

The investigators aim to analyze whether an adjusted supramarginal resection guided by these new recurrence probability maps improves survival in selected patients with glioblastoma.

Description:

The SupraGlio-AI study aims to test the feasibility of the proposed AI-guided tailored supratotal resection for glioblastomas. The study will provide preliminary data on the accuracy of the AI model in predicting recurrence and the impact of using this information in surgical planning. This information will be crucial in determining the potential for a larger, randomized controlled trial in the future. The pilot study will also allow for refinement of the study design, intervention, and data collection processes before a larger-scale study is conducted. In addition to testing the feasibility and efficacy of the AI-guided tailored supratotal resection, this pilot study also has two secondary objectives: 1) Survival Analysis: A survival analysis will be performed to compare the prospective cohort of patients undergoing the AI-guided procedure with a retrospective cohort of glioblastoma patients who underwent standard gross total resection. The survival analysis will provide insights into the impact of using the AI model on patient outcomes and help determine the potential benefits of this approach. 2) Histopathological and Transcriptomic Analysis: The study will also include a histopathological and transcriptomic analysis of the tissue samples obtained from the high-risk regions defined by the AI model. This analysis will provide information on the molecular and cellular changes occurring in these regions and may offer insights into the underlying biology of glioblastoma recurrence. These data will inform the development of future studies aimed at improving patient outcomes.

By incorporating these secondary objectives, this pilot study will contribute to a more comprehensive understanding of the potential benefits of using AI in guiding tailored supratotal resection for glioblastomas. The results will inform future research and potentially lead to the development of improved treatment approaches for patients with this type of brain tumor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• A suspected diagnosis of supratentorial glioblastoma by MRI.

• Tumor in non eloquent brain region according to the UCSF (University of California, San Francisco) classification, including the sensor motor areas (precentral and postcentral gyri), perisylvian language areas in the dominant hemisphere (superior temporal, inferior frontal, and inferior parietal gyri), basal ganglia, internal capsule, thalamus, and visual cortex around the calcarine sulcus

• Indication for surgical treatment and where supramarginal resection is considered possible according to the preoperative imaging. This consideration needs to be verified by two specialists in neurosurgery. This criterion needs to be verified by two senior neurosurgeons.

• Karnofsky Performance Score = 60;

• Written informed consent

Exclusion Criteria:

• Tumors in eloquent areas.

• Recurrent gliomas (except biopsy)

• MR image data not usable due to artifacts during acquisition. Inability to give written informed consent

• KPS < 60

• Severe comorbidity.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Procedure:
• GTR surgery
Gross total resection of the enhancing tumor volume
• AI-guided surgery
Supramarginal resection including high-risk areas of recurrence

Locations

Country	Name	City	State
Spain	Hospital Universitario de La Princesa	Madrid
Spain	University Hospital Rio Hortega	Valladolid

Sponsors (7)

Lead Sponsor

Collaborator

Hospital del Río Hortega

Biomedical Engineering Group (GIB) - University of Valladolid - Research Unit 060, Castilla y León, Department of Physics and Technology, UiT The Arctic University of Norway, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Intracellular Calcium Pathophysiology Group - Institute of Biology and Molecular Genetics (IBGM) - Research Unit 093, Castilla y León, The PET Imaging Center, University Hospital of North Norway, UiT Machine Learning Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility using eligibility	Among all screened patients, the proportion of patients who meet the eligibility criteria	Screening/Enrollment
Primary	Feasibility using the proportion of consent	Among all screened patients, the proportion of patients consenting to participate	Screening/Enrollment
Secondary	Efficacy using overall survival	Measured in days from surgery to the time of death	From date of surgery until the date of death from any cause, assessed up to 36 months
Secondary	Efficacy using progression-free survival	Assessment of progression-free survival based on the Modified Criteria for Radiographic Response Assessment in Glioblastoma (mRANO) criteria.	From date of surgery until the date of first documented progression, assessed up to 36 months
Secondary	Safety using the neurological function	The National Institutes of Healt Stroke Scale (NIHSS) will be used to assess neurological function. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.	30 days
Secondary	Safety using global disability	The modified Rankin scale (mRS ) is a measure of global disability that has been widely used to assess outcome after stroke. The scale runs from 0-6, running from perfect health without symptoms to death	30 days
Secondary	Extent of resection	Volumetric measurement of contrast enhancement and T2-FLAIR signal alteration on MRI	< 72 hours after surgery
Secondary	Postoperative complication	Relevant post surgical complication that requires a second surgery or prolong the length of hospitalization (i.e. hematoma, infection)	30 days