Actively Recruiting

Age: 18Years +
All Genders
NCT07567196

PET-Guided Resection in High-Grade Gliomas

Led by Universita degli Studi di Genova · Updated on 2026-05-05

100

Participants Needed

2

Research Sites

404 weeks

Total Duration

On this page

Sponsors

U

Universita degli Studi di Genova

Lead Sponsor

U

University of Turin, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PET-Guided Resection in High-Grade Gliomas

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with high-grade glioma (WHO grade III or IV) on MRI
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Tumors located in the cerebellum, brainstem, or midline
  • Medical conditions preventing MRI (e.g., pacemaker)
  • Unable to provide written informed consent
  • Secondary high-grade gliomas from low-grade glioma transformation
  • Other primary malignancy within the past 5 years

AI-Screening

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Trial Site Locations

Total: 2 locations

1

AOU Città della Salute e della Scienza

Torino, Turin, Italy, 10126

Actively Recruiting

2

IRCCS Azienda Ospedaliera Metropolitana

Genova, Italy, 16100

Actively Recruiting

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Research Team

A

Andrea Bianconi, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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