Actively Recruiting
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
Eligibility Criteria
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
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
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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