PET-Guided Resection in High-Grade Gliomas

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversita degli Studi di Genova

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Overall Survival

Time from surgical resection to death from any cause

Time frame
From date of surgery until the date of death from any cause, whichever comes first, assessed up to 60 months.
2

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

Time frame
From date of surgery until the date of disease progression or death from any cause, whichever comes first, assessed up to 60 months.

Secondary outcomes

1

Histopathological Correlation of PET Hypercaptant Areas

Proportion of PET-positive regions beyond contrast enhancement that contain viable neoplastic cells on histopathological examination

Time frame
At time of surgical resection (Day 0)
2

Extent of Resection

Percentage of tumor volume resected, comparing PET-defined tumor volume versus MRI-defined tumor volume (contrast-enhancing and FLAIR hyperintensity)

Time frame
Within 72 hours and 30 days post-surgery (postoperative MRI and PET)

Other outcomes

Sponsors and contacts

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Universita degli Studi di Genova

Lead sponsor

University of Turin, Italy

Collaborator