NCT07567196 PET-Guided Resection in High-Grade Gliomas
| NCT ID | NCT07567196 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universita degli Studi di Genova |
| Condition | Glioma Glioblastoma Multiforme |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-04-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07567196 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma Glioblastoma Multiforme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07567196 currently recruiting?
Yes, NCT07567196 is actively recruiting participants. Contact the research team at andrea.bianconi@unige.it for enrollment information.
Where is the NCT07567196 trial being conducted?
This trial is being conducted at Torino, Italy, Genova, Italy.
Who is sponsoring the NCT07567196 clinical trial?
NCT07567196 is sponsored by Universita degli Studi di Genova. The trial plans to enroll 100 participants.
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