NCT05735171Completed
Supramarginal Resection in Glioblastoma Guided by Artificial Intelligence
Tailored Supramarginal Resection in Glioblastoma Guided by Artificial Intelligence-based Recurrence Probability Maps. A Non-randomized Pilot Study
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 7 Feb 2023
- Start date
- 1 Nov 2022
- Primary completion date
- 30 May 2025
- Lead sponsor
- Hospital del Rio Hortega
- Diseases
- Glioblastoma
- NCT number
- NCT05735171
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Nov 2022 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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 \< 70
- Severe comorbidity.
Who the study is looking for
- 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 ≥ 70;
- Written informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
Related publications
- Prospective biopsy-controlled validation of an AI model for predicting glioblastoma infiltration: Results from the SupraGlio trial.Neuro Oncol · 2026 · PMID 42010946
This page is information, not medical advice. Discuss any trial with your doctor.