About this trial
Background: Glioblastoma (GBM) is the most common primary brain tumor in adults, with a poor prognosis despite maximal treatment. Current evidence suggests that supramaximal resection, including non-enhancing FLAIR-hyperintense regions, improves survival. However, the extent of FLAIR resection is often limited by functional constraints and its non-specific nature, as it may represent both tumor infiltration and peritumoral edema. This study explores the role of 18F-DOPA PET in refining supramaximal resection by providing a more specific surgical target beyond contrast-enhancing areas.
Objective: To evaluate the impact of 18F-DOPA PET-guided resection on progression-free survival (PFS) and overall survival (OS) in GBM patients, by comparing outcomes between those undergoing PET-RM integrated resection versus conventional MRI-guided resection.
Methods: ResPGlioma is a multicenter, prospective, non-randomized study conducted at IRCCS Ospedale Policlinico San Martino (Genoa) and AOU Città della Salute e della Scienza (Turin). Patients with newly diagnosed, supratentorial, high-grade gliomas undergo preoperative 18F-DOPA PET and MRI. Surgery follows the principle of maximal safe resection, with postoperative MRI at 48 hours assessing the extent of resection (EOR). To confirm PET resection or non-PET resection status, patients will undergo a postoperative 18F-DOPA PET scan at 30 ± 7 days following surgery, prior to the initiation of chemoradiotherapy. Patients are categorized based on EOR criteria (RANO) and PET volume resection (PET-resection vs. PET non-resection). Statistical analyses include Kaplan-Meier survival curves and regression models to identify prognostic factors.Patients are categorized based on EOR criteria (RANO) and PET volume resection (PET-resection vs. PET non-resection). Statistical analyses include Kaplan-Meier survival curves and regression models to identify prognostic factors.
Expected Outcomes: The authors hypothesize that PET-guided resection improves PFS and OS by enabling a more precise tumor removal beyond contrast-enhancing margins while preserving neurological function. Preliminary data support that PET hypercaptant areas contain viable tumor cells and should be resected. This approach may offer a more accessible yet effective alternative to FLAIR-guided supramaximal resection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥18 years
high-grade glioma (WHO grade III/IV) diagnosed on MRI
provide written informed consent
Disqualifiers
tumors located in the cerebellum, brainstem, or midline.
Patients with medical conditions precluding MRI
inability to provide written informed consent
secondary high-grade gliomas resulting from malignant transformation of a low-grade glioma
Trial population
The study population includes adult patients diagnosed with high-grade glioma, located supratentorially and eligible for surgical resection. Inclusion criteria consist of age ≥18 years, have a high-grade glioma (WHO grade III/IV) diagnosed on MRI as assessed by the neurosurgeon, and provide written informed consent. Exclusion criteria include tumors located in the cerebellum, brainstem, or midline. Patients with medical conditions precluding MRI, such as those with a pacemaker, are not eligible. Other exclusion criteria include the inability to provide written informed consent, secondary high-grade gliomas resulting from malignant transformation of a low-grade glioma, and a second primary malignancy within the past five years.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Overall Survival
Time from surgical resection to death from any cause
Progression Free Survival
Time from surgical resection to first documented disease progression (assessed by MRI according to RANO 2.0 criteria) or death from any cause, whichever occurs first
Secondary outcomes
Histopathological Correlation of PET Hypercaptant Areas
Proportion of PET-positive regions beyond contrast enhancement that contain viable neoplastic cells on histopathological examination
Extent of Resection
Percentage of tumor volume resected, comparing PET-defined tumor volume versus MRI-defined tumor volume (contrast-enhancing and FLAIR hyperintensity)
Sponsors and contacts
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Universita degli Studi di Genova
Lead sponsor
University of Turin, Italy
Collaborator