The added value of apparent diffusion coefficient to cerebral blood volume in the preoperative grading of diffuse gliomas.
A Hilario, A Ramos, A Perez-Nuñez...
https://pubmed.ncbi.nlm.nih.gov/22207304Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06975332
Assessment of Efficacy and Safety of Local Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP in Recurrent High-Grade Glioma (WHO G3-G4)
Led by Medical University of Warsaw · Updated on 2025-05-16
35
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Brain tumors, including gliomas, are serious conditions that make up a significant portion of central nervous system tumors and cause a notable number of cancer-related deaths. Malignant gliomas particularly have a low survival rate despite standard treatments like surgery, radiotherapy, and chemotherapy. This research aims to evaluate the safety and effectiveness of a new local targeted therapy using the alpha-emitting neuropeptide [225Ac]Ac-DOTA-SP in patients with recurrent high-grade gliomas (WHO grade 3 and 4) after initial therapy. The study is interventional and led by the Medical University of Warsaw with contributions from neurosurgery and nuclear medicine experts. Participants will receive up to six cycles of [225Ac]Ac-DOTA-SP administered directly into the tumor or resection cavity through a catheter placed during a surgical procedure. Before treatment, imaging using PET/CT with specific tracers will guide catheter placement and assess distribution. The therapy involves a slow infusion of the radiopharmaceutical combined with supportive intravenous medications and brain imaging to monitor delivery. Hospitalization for several days is required for catheter placement and treatment administration, with close monitoring for side effects such as seizures. Throughout the study, participants will undergo regular blood and urine tests, neurological assessments, MRI scans every two months, and follow-up visits that may include telemedicine for up to 18 months or longer. The main outcomes measured are clinical and radiological progression of the glioma, with overall survival and progression-free survival as key endpoints. Biological samples will also be collected during surgery for further analysis. Patient data will be anonymized and securely stored for research purposes. The study is expected to last three years with ongoing monitoring of survival for participants alive at the end.
CONDITIONS
Brief Title
Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Histologically confirmed diffuse glioma (WHO CNS grade 3 or 4)
- Completed standard treatment including biopsy or resection, radiotherapy, and/or chemotherapy
- Evidence of tumor progression on MRI as defined by RANO 2.0 criteria
- Unifocal lesion present
- Tumor volume less than 50 ml and thickness under 1 cm after resection
- Tumor median diameter less than 2 cm after biopsy
- Functional status above 70 on Karnofsky Performance Scale
- Able to provide informed consent to participate
You will not qualify if you...
- Need for urgent surgery such as sudden increase in intracranial pressure
- Significant postoperative complications including Karnofsky performance scale below 70, wound infection, or cerebrospinal fluid leak
- Ventricular shunt leak greater than 10% during control test
- Open or communicating resection cavity
- Mass effect with midline shift over 5 mm or symptoms like nausea, vomiting, altered consciousness, or significant papilledema
- Catheter obstruction
- Life expectancy predicted to be less than 3 months
- Lack of preserved logical-verbal contact or uncooperative behavior
- Unable to provide informed voluntary consent
- Participation in another medical experiment
- Use of any investigational drug within 1 month before first dose
- Prior treatment with [225Ac]Ac-DOTA-SP
- Breastfeeding or pregnancy
- Severe diseases of other organs increasing procedural risk per investigator's opinion
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 (qualification visit)
Reoperation with Catheter Placement
Duration - Several days
Participants undergo reoperation involving tumor biopsy or resection and catheter placement in the brain for subsequent treatment delivery. This requires several days of hospitalization.
Hospitalization for catheter placement lasting several days
Pre-Treatment Assessment
Duration - Approximately 1 week before treatment
Participants have catheter patency checked about one week before treatment, including local administration of a tracer and brain imaging to assess biodistribution.
1 visit for catheter patency check and PET/CT imaging
Local Targeted Therapy
Duration - Up to 6 cycles over several months
Participants receive up to 6 cycles of local targeted therapy with the alpha-emitter [225Ac]Ac-DOTA-SP administered to the post-resection cavity via catheter with forced diffusion. Each cycle is followed by monitoring and imaging to assess treatment distribution and effects.
Each cycle includes approximately 3 days of hospitalization and multiple imaging and laboratory assessments
Follow-up
Duration - Up to 18 months with regular visits and continued monitoring thereafter
Participants are monitored regularly after treatment to assess health status, treatment efficacy, and any adverse effects. MRI scans are performed every 2 months initially, then every 3 months or more frequently as needed.
Visits every 2 months during the first 18 months, then every 3 months or as needed (including telemedicine options)
Trial Site Locations
Total: 2 locations
1
Department of Neurosurgery, Medical University of Warsaw, Banacha 1a
Warsaw, Poland, Poland, 02-097
Actively Recruiting
2
Department of Neurosurgery, National Instiute of Oncology, W.K. Roentgena 5
Warsaw, Poland, Poland, 02-781
Actively Recruiting
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Research Team
P
Przemysław Kunert, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
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Eva Syková, Charles Nicholson
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D Cordier, F Forrer, F Bruchertseifer...
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Dominik Cordier, Flavio Forrer, Stefan Kneifel...
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Leszek Królicki, Frank Bruchertseifer, Jolanta Kunikowska...
https://pubmed.ncbi.nlm.nih.gov/33860346Safety and efficacy of targeted alpha therapy with 213Bi-DOTA-substance P in recurrent glioblastoma.
Leszek Królicki, Frank Bruchertseifer, Jolanta Kunikowska...
https://pubmed.ncbi.nlm.nih.gov/30498897Locoregional Treatment of Glioblastoma With Targeted α Therapy: [ 213 Bi]Bi-DOTA-Substance P Versus [ 225 Ac]Ac-DOTA-Substance P-Analysis of Influence Parameters.
Leszek Królicki, Jolanta Kunikowska, Frank Bruchertseifer...
https://pubmed.ncbi.nlm.nih.gov/36854309