Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Brain tumors account for 1.35% of all cancers and cause 2.2% of cancer-related deaths. Gliomas are the most common type, comprising 40-90% of central nervous system tumors in different age groups. The incidence of malignant gliomas is approximately 0.5-2 per 100,000 people annually. Standard treatments include surgical resection, radiotherapy, and chemotherapy, yet overall survival remains low, typically 1-3 years post-diagnosis. The study highlights the pressing need for novel treatment strategies, particularly given the infiltrative nature of gliomas and the potential for targeted therapies using neuropeptides. The aim of this study is to assess the efficacy and safety of local targeted therapy with \[225Ac\]Ac-DOTA-SP in recurrent glioblastoma. It is an interventional study without a control group, initiated by the researcher. Patients included are aged 18-80 with recurrent WHO G3-G4 glioma post-first-line treatment, not requiring immediate surgery and meeting specific MRI progression criteria. Patients will receive a maximum of six cycles of \[225Ac\]Ac-DOTA-SP, involving pre-treatment assessments, local administration of the agent after ensuring catheter patency, and continuous monitoring. Blood tests and neurological evaluations will be performed regularly. Outcome will be assessed by measuring overall survival (OS) and progression-free survival (PFS). The study anticipates improvements in both OS and PFS when compared to current treatments, contributing to critical insights into targeted alpha therapy's effectiveness in glioblastoma. Treatment with \[225Ac\]Ac-DOTA-SP previously indicated few significant side effects, primarily transient issues like seizures. Patients will be closely monitored throughout the study to identify any adverse effects promptly. The estimated study duration is three years, with biological material collected for histopathological and genetic analysis during surgical reoperation. Data will be anonymized to protect patient confidentiality, stored securely, and made available only for the scope of the study. Led by Prof. Przemysław Kunert, the research team includes multiple co-investigators from neurosurgery and nuclear medicine departments.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-80 lat
- •Potwierdzony rozpoznaniem histologicznym glejaka WHO klasy G3-G4
- •Wcześniejsze leczenie chirurgiczne lub biopsja oraz radiochemioterapia
- •Potwierdzony wzrost guza w badaniu MRI (progresja)
- •Jeden ognisko guza
- •Dobry stan ogólny (powyżej 70 punktów w skali Karnofskiego)
- •Możliwość wyrażenia świadomej zgody na udział w badaniu
✗ Disqualifies
- •Potrzeba pilnego zabiegu chirurgicznego
- •Poważne powikłania po zabiegu (zakażenie rany, wyciek płynu mózgowo-rdzeniowego)
- •Niedrożność cewnika
- •Obrzęk mózgu z przesunięciem śródlinią powyżej 5 mm
- •Spodziewana długość życia poniżej 3 miesięcy
- •Pacjenci z zaburzeniami świadomości lub niedooperacyjni
- •Ciąża lub karmienie piersią
- •Udział w innym badaniu medycznym
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Last updated (source)
- October 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
Department of Neurosurgery, Medical University of Warsaw, Banacha 1a
Warsaw, Poland
Department of Neurosurgery, National Instiute of Oncology, W.K. Roentgena 5
Warsaw, Poland
Trial contact
Przemysław Kunert, Professor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/14/2026.
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