PET-Guided Resection in High-Grade Gliomas

Recruiting now

Conditions studied: Glioma Glioblastoma Multiforme, Glioma, High Grade, Glioma Surgery, Positron-Emission Tomography(PET)

In brief

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.

Key facts

Study ID: NCT07567196
Run by: Universita degli Studi di Genova
People needed: 100
Starts: 2022-04-01
Expected to finish: 2029-12-31
Last updated by the study team: 2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

age ≥18 years
high-grade glioma (WHO grade III/IV) diagnosed on MRI
provide written informed consent

You may not qualify if…

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
other primary malignancy within the past five years

Where it is running

AOU Città della Salute e della Scienza — Torino, Turin, Italy (enrolling)
IRCCS Azienda Ospedaliera Metropolitana — Genova, Italy (enrolling)

Full record on ClinicalTrials.gov

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