Actively Recruiting
Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression
Led by Medical University of Warsaw · Updated on 2025-05-16
35
Participants Needed
2
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Histologically confirmed diffuse glioma classified as CNS WHO grade 3 or 4
- Completed standard treatment including biopsy or resection, radiotherapy, and/or chemotherapy
- Tumor progression confirmed by RANO 2.0 criteria on MRI
- Single tumor lesion
- After resection: tumor volume less than 50 ml and tumor tissue thickness under 1 cm on contrast-enhanced MRI
- After biopsy: tumor median diameter less than 2 cm
- Karnofsky Performance Status above 70
- Ability to give informed consent to participate in the study
You will not qualify if you...
- Urgent need for surgery due to clinical conditions
- Significant postoperative complications such as Karnofsky Performance Status below 70, wound infection, or cerebrospinal fluid leak
- Ventricular shunt leak greater than 10% on patency test
- Open or communicating resection cavity
- Significant mass effect on imaging causing midline brain shift over 5 mm or clinical symptoms like nausea, vomiting, altered consciousness, or papilledema
- Catheter obstruction
- Life expectancy less than three months
- Lack of preserved logical-verbal contact or uncooperative behavior
- Inability to provide informed voluntary consent
- Participation in another clinical trial
- Use of any investigational drug within one month before first dose
- Prior treatment with [225Ac]Ac-DOTA-SP
- Pregnancy or breastfeeding
- Severe other organ diseases increasing procedural risk as judged by the investigator
AI-Screening
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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
Research Team
P
Przemysław Kunert, Professor
CONTACT
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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