A Systematic Review of Amino Acid PET Imaging in Adult-Type High-Grade Glioma Surgery: A Neurosurgeon's Perspective.
Raffaele De Marco, Alessandro Pesaresi, Andrea Bianconi...
https://pubmed.ncbi.nlm.nih.gov/36612085Actively Recruiting
Age: 18Years +
All Genders
ID07567196
ResPGlioma: Impact of PET-Guided Resection on Survival in High-Grade Gliomas - A Multicenter Prospective Study
Led by Universita degli Studi di Genova · Updated on 2026-05-05
100
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
Universita degli Studi di Genova
Lead Sponsor
U
University of Turin, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Glioblastoma (GBM) is the most common and aggressive primary brain tumor in adults, with a poor outlook despite current treatments. Researchers are studying whether using 18F-DOPA PET imaging to guide brain tumor surgery can improve survival by targeting tumor areas beyond those seen on standard MRI scans. This study compares outcomes between patients who have PET-guided tumor removal and those who have surgery guided only by conventional MRI. Patients with newly diagnosed, high-grade gliomas in the upper brain will have preoperative PET and MRI scans. Surgeons aim for maximal safe tumor removal using these images, collecting tissue samples from different tumor regions for detailed analysis. After surgery, patients undergo follow-up MRI and PET scans to assess how much tumor was removed and to categorize them based on PET-guided resection status. The study lasts four years and includes phases for preparation, recruitment, data analysis, and sharing results. During the study, participants will have multiple imaging tests, surgery with tissue sampling, and regular follow-up visits to track tumor progression and survival. Researchers will analyze survival times, molecular tumor features, and imaging data to understand the benefits of PET-guided surgery. Safety and neurological function will be monitored throughout, with data collected up to five years after surgery.
CONDITIONS
Brief Title
PET-Guided Resection in High-Grade Gliomas
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with high-grade glioma (WHO grade III or IV) based on MRI
- Able and willing to provide written informed consent
You will not qualify if you...
- Tumors located in the cerebellum, brainstem, or midline
- Medical conditions that prevent having an MRI scan
- Unable to provide written informed consent
- Secondary high-grade gliomas from low-grade glioma transformation
- Other primary malignancy within the past five years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Diagnostic Evaluation
Duration - Within 1 week before surgery
Participants undergo preoperative 18F-DOPA PET and MRI scans to assess tumor characteristics and guide surgical planning.
1 to 2 visits for PET and MRI imaging
Surgery and Immediate Post-operative Care
Duration - Day 0 (Surgery day) plus immediate recovery period
Participants undergo surgical resection guided by PET and MRI imaging, with tissue samples collected for histopathological analysis.
1 surgical procedure with hospital stay for immediate post-operative care
Post-operative Follow-up
Duration - Within 30 days after surgery
Participants receive MRI within 72 hours and 18F-DOPA PET around 30 days post-surgery to evaluate extent of resection and residual tumor activity.
2 imaging visits (MRI and PET) post-surgery
Long-term Monitoring
Duration - Up to 60 months
Participants are followed longitudinally to track progression-free survival and overall survival through regular clinical assessments.
Regular follow-up visits scheduled by neuro-oncology teams
Trial Site Locations
Total: 2 locations
1
AOU Città della Salute e della Scienza
Torino, Turin, Italy, 10126
Actively Recruiting
2
IRCCS Azienda Ospedaliera Metropolitana
Genova, Italy, 16100
Actively Recruiting
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Research Team
A
Andrea Bianconi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
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.
Ian Law, Nathalie L Albert, Javier Arbizu...
https://pubmed.ncbi.nlm.nih.gov/30519867The oncological role of resection in newly diagnosed diffuse adult-type glioma defined by the WHO 2021 classification: a Review by the RANO resect group.
Philipp Karschnia, Jasper K W Gerritsen, Nico Teske...
https://pubmed.ncbi.nlm.nih.gov/39214112FLAIRectomy: Resecting beyond the Contrast Margin for Glioblastoma.
Alexander F Haddad, Jacob S Young, Ramin A Morshed...
https://pubmed.ncbi.nlm.nih.gov/35624931Challenges, limitations, and pitfalls of PET and advanced MRI in patients with brain tumors: A report of the PET/RANO group.
Norbert Galldiks, Timothy J Kaufmann, Philipp Vollmuth...
https://pubmed.ncbi.nlm.nih.gov/38466087