NCT07488754Recruiting
Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) In Newly Diagnosed Glioma (WHO G3-G4)
Medical Experiment - Assessment of Efficacy & Safety of Local, Targeted Therapy With Neuropeptide Labelled With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) as Supplementary Therapy Following Standard Treatment Of Glioma (WHO G3-G4)
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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 newly diagnosed glioblastoma following standard treatment.It is an interventional study without a control group, initiated by the researcher. Patients included are aged 18-80 with WHO G3-G4 glioma post-first-line treatment, not requiring immediate surgery and meeting specific MRI 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- 1 Oct 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Medical University of Warsaw
- Diseases
- Glioblastoma
- NCT number
- NCT07488754
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 1 Oct 2025 to the primary completion date, Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- radiation-induced necrosis secondary to radiotherapy; may occur within the first 3 months after radiotherapy (exception: a patient after resection of radiation necrosis - not earlier than 4 weeks post-surgery, after a follow-up MRI);
- need for emergency surgery (e.g., acute increase in intracranial pressure);
- open/ventricle-connected resection cavity;
- patients who received any other investigational drug within 1 month prior to the first dose;
- prior treatment with \[225Ac\]Ac-DOTA-SP;
Other illness
- progression or recurrence defined as: deterioration of the patient's condition according to the Karnofsky Performance Scale, worsening of neurological function, progressive neurological deficit, need to initiate or increase corticosteroid dose by \>50%, progression or recurrence assessed on MRI (RANO criteria);
- significant postoperative complications, e.g., KPS \< 70, wound infection, cerebrospinal fluid leak;
- severe comorbid organ diseases that, in the Investigator's opinion, significantly increase the procedural risk.
Other
- low-grade glioma;
- leak into the ventricular system \>10% during the catheter patency check;
- catheter obstruction;
- estimated life expectancy under 3 months;
- patients without preserved logical/verbal contact;
- lack of cooperation from the patient;
- inability to give informed, voluntary consent to participate in the study;
- patients enrolled in another medical trial;
- breastfeeding or pregnant women;
Who the study is looking for
- age 18-80;
- histologically confirmed diffuse glioma (CNS WHO G3-G4);
- after standard treatment with biopsy or resection, radiotherapy and/or chemotherapy;
- no sign of progression or radiation necrosis;
- functional state \>70 according to Karnofsky's performance scale (KPS);
- ability to give informed consent to participate in the study.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurosurgery, National Instiute of Oncology, W.K. Roentgena 5 Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Department of Neurosurgery, Medical University of Warsaw, Banacha 1a Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.