RecruitingNCT07567196

PET-Guided Resection in High-Grade Gliomas

ResPGlioma: Impact of PET-Guided Resection on Survival in High-Grade Gliomas - A Multicenter Prospective Study


Sponsor

Universita degli Studi di Genova

Enrollment

100 participants

Start Date

Apr 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria5

  • 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

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Locations(2)

AOU Città della Salute e della Scienza

Torino, Turin, Italy

IRCCS Azienda Ospedaliera Metropolitana

Genova, Italy

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NCT07567196


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