PET-Guided Resection in High-Grade Gliomas

NCT07567196 | Recruiting

• 1 other identifier: 698.050
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Glioma Glioblastoma Multiforme; Glioma, High Grade; Glioma Surgery; Positron-Emission Tomography(PET)

Keywords

glioma; glioblastoma; PET

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Time from surgical resection to death from any cause

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

• 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

  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 (2)

• Histopathological Correlation of PET Hypercaptant Areas

  At time of surgical resection (Day 0)

• Extent of Resection

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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

Sponsors & Collaborators

• Universita degli Studi di Genova: lead
• University of Turin, Italy: collaborator

Study Sites (2)

AOU Città della Salute e della Scienza

Torino, Turin, 10126, Italy

RECRUITING

IRCCS Azienda Ospedaliera Metropolitana

Genova, 16100, Italy

RECRUITING

Related Publications (5)

• De Marco R, Pesaresi A, Bianconi A, Zotta M, Deandreis D, Morana G, Zeppa P, Melcarne A, Garbossa D, Cofano F. A Systematic Review of Amino Acid PET Imaging in Adult-Type High-Grade Glioma Surgery: A Neurosurgeon's Perspective. Cancers (Basel). 2022 Dec 23;15(1):90. doi: 10.3390/cancers15010090.

  PMID: 36612085 BACKGROUND

• Law I, Albert NL, Arbizu J, Boellaard R, Drzezga A, Galldiks N, la Fougere C, Langen KJ, Lopci E, Lowe V, McConathy J, Quick HH, Sattler B, Schuster DM, Tonn JC, Weller M. Joint EANM/EANO/RANO practice guidelines/SNMMI procedure standards for imaging of gliomas using PET with radiolabelled amino acids and [18F]FDG: version 1.0. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):540-557. doi: 10.1007/s00259-018-4207-9. Epub 2018 Dec 5.

  PMID: 30519867 BACKGROUND

• Karschnia P, Gerritsen JKW, Teske N, Cahill DP, Jakola AS, van den Bent M, Weller M, Schnell O, Vik-Mo EO, Thon N, Vincent AJPE, Kim MM, Reifenberger G, Chang SM, Hervey-Jumper SL, Berger MS, Tonn JC. The oncological role of resection in newly diagnosed diffuse adult-type glioma defined by the WHO 2021 classification: a Review by the RANO resect group. Lancet Oncol. 2024 Sep;25(9):e404-e419. doi: 10.1016/S1470-2045(24)00130-X.

  PMID: 39214112 BACKGROUND

• Haddad AF, Young JS, Morshed RA, Berger MS. FLAIRectomy: Resecting beyond the Contrast Margin for Glioblastoma. Brain Sci. 2022 Apr 25;12(5):544. doi: 10.3390/brainsci12050544.

  PMID: 35624931 BACKGROUND

• Galldiks N, Kaufmann TJ, Vollmuth P, Lohmann P, Smits M, Veronesi MC, Langen KJ, Ruda R, Albert NL, Hattingen E, Law I, Hutterer M, Soffietti R, Vogelbaum MA, Wen PY, Weller M, Tonn JC. Challenges, limitations, and pitfalls of PET and advanced MRI in patients with brain tumors: A report of the PET/RANO group. Neuro Oncol. 2024 Jul 5;26(7):1181-1194. doi: 10.1093/neuonc/noae049.

  PMID: 38466087 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Andrea Bianconi, MD

CONTACT

+393475805577; andrea.bianconi@unige.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 5, 2026
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available beginning 6 months after publication and will remain accessible for 5 years
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal for meta-analysis or validation studies

Locations

IT (2)