Clinical trial · Observational
PET-Guided Resection in High-Grade Gliomas
ResPGlioma: Impact of PET-Guided Resection on Survival in High-Grade Gliomas - A Multicenter Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma Glioblastoma Multiforme | — | UNRESOLVED | — |
| Glioma, High Grade | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
| Glioma Surgery | — | UNRESOLVED | — |
| Positron-Emission Tomography(PET) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Overall Survival
- timeFrame
- From date of surgery until the date of death from any cause, whichever comes first, assessed up to 60 months.
- description
- Time from surgical resection to death from any cause
- measure
- Progression Free Survival
- timeFrame
- From date of surgery until the date of disease progression or death from any cause, whichever comes first, assessed up to 60 months.
- description
- 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
Secondary outcomes (2)
- measure
- Histopathological Correlation of PET Hypercaptant Areas
- timeFrame
- At time of surgical resection (Day 0)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥18 years * high-grade glioma (WHO grade III/IV) diagnosed on MRI * provide written informed consent Exclusion Criteria: * 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
References
Publications (5)
- BACKGROUNDDe 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
- BACKGROUNDLaw 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
- BACKGROUNDKarschnia 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
- BACKGROUNDHaddad 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
- BACKGROUNDGalldiks 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