Clinical trial NCT05735171: Supramarginal Resection in Glioblastoma Guided by Artificial Intelligence
Official title: Tailored Supramarginal Resection in Glioblastoma Guided by Artificial Intelligence-based Recurrence Probability Maps. A Non-randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glioblastoma
Lead sponsor: Hospital del Rio Hortega
Sponsor class: OTHER
Collaborators: name: UiT The Arctic University of Norway
name: University Hospital of North Norway
name: University of Valladolid
First posted: 2023-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility using eligibility
timeFrame: Screening/Enrollment
measure: Feasibility using the proportion of consent
timeFrame: Screening/Enrollment
Secondary outcomes:
measure: Efficacy using overall survival
timeFrame: From date of surgery until the date of death from any cause, assessed up to 36 months
measure: Efficacy using progression-free survival
timeFrame: From date of surgery until the date of first documented progression, assessed up to 36 months
measure: Safety using the neurological function
timeFrame: 30 days
measure: Safety using global disability
timeFrame: 30 days
measure: Extent of resection
timeFrame: < 72 hours after surgery
measure: Postoperative complication
timeFrame: 30 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Valladolid
country: Spain
facility: University Hospital Rio Hortega
Study officials:
affiliation: Hospital Río Hortega
name: Santiago Cepeda, PhD
role: PRINCIPAL_INVESTIGATOR
References: