PET-guided surgery for high-grade glioma
ResPGlioma: Impact of PET-Guided Resection on Survival in High-Grade Gliomas - A Multicenter Prospective Study
Universita degli Studi di Genova · NCT07567196
This project will try using 18F-DOPA PET to guide surgeons to remove tumor beyond MRI-visible areas in adults with high-grade glioma to see if it delays progression and extends survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universita degli Studi di Genova (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Torino, Turin and 1 other locations) |
| Trial ID | NCT07567196 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective, non-randomized observational comparison of 18F-DOPA PET-guided resection versus conventional MRI-guided resection in patients with high-grade glioma. Surgeons integrate PET metabolic maps with standard MRI to define targets for supramaximal resection beyond contrast-enhancing regions and FLAIR abnormalities. Outcomes include progression-free survival and overall survival, with preoperative imaging, surgical extent-of-resection metrics, and follow-up clinical and radiographic assessments. The study enrolls adult surgical candidates at participating centers in Genoa and Turin, Italy.
Who should consider this trial
Good fit: Adults (≥18 years) with newly diagnosed high-grade glioma (WHO grade III/IV) who are candidates for surgical resection and can undergo MRI and PET and provide informed consent.
Not a fit: Patients with tumors in the cerebellum, brainstem, midline, or those who are not surgical candidates or cannot undergo MRI/PET are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, PET guidance could help surgeons remove more tumor while sparing healthy brain, potentially prolonging progression-free and overall survival.
How similar studies have performed: Prior small series and imaging-pathology studies have shown that amino-acid PET can detect tumor beyond MRI margins and correlate with infiltrative disease, but larger prospective comparative data are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Torino, Turin and 1 other locations
- AOU Città della Salute e della Scienza — Torino, Turin, Italy (RECRUITING)
- IRCCS Azienda Ospedaliera Metropolitana — Genova, Italy (RECRUITING)
Study contacts
- Study coordinator: Andrea Bianconi, MD
- Email: andrea.bianconi@unige.it
- Phone: +393475805577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioma Glioblastoma Multiforme, Glioma, High Grade, Glioma Surgery, Positron-Emission Tomography, glioma, glioblastoma, PET