Local targeted therapy for recurrent glioblastoma using alpha emitter.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of a local targeted therapy using the alpha emitter [225Ac]Ac-DOTA-SP in patients with recurrent high-grade gliomas (WHO G3-G4) who have undergone standard treatments. The study focuses on patients aged 18-80 with specific MRI-defined tumor progression and aims to provide a novel treatment option for this challenging condition. It is an interventional study without a control group, initiated by the researcher, and seeks to address the pressing need for improved therapeutic strategies in glioma management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age 18-80;
* histologically confirmed diffuse glioma (CNS WHO G3-G4);
* after standard treatment with biopsy or resection, radiotherapy and/or chemotherapy;
* tumour progression as defined by RANO 2.0 on MRI (hyperintense lesion on MRI or increase of maximal transverse diameter of tumour or increase on volumetric measurement, local progression by continuity in proximity of 4 cm to primary lesion after resection, stable lesion progression on MRI \>25% in time between two consecutive MRIs or any new lesion on MRI; to differentiate progression from pseudoprogression a biopsy may be needed, especially within 12 weeks from radiotherapy);
* unifocal lesion;
* after resection: tumour volume \<50 ml AND tumour tissue thickness on contrast-enhanced T1 MRI \<1 cm;
* after biopsy: tumour median diameter \<2 cm;
* functional state \>70 according to Karnofsky's performance scale (KPS);
* ability to give informed consent to participate in the study.

Exclusion criteria:

* necessity of urgent surgery (e.g., sudden increase in intracranial pressure);
* significant postoperative complications: e.g., Karnofsky's performance scale (KPS) \<70, wound infection, cerebrospinal fluid leak;
* ventricular shunt leak \>10% during a control patency test;
* open/communicating resection cavity;
* mass effect on CT scan or MRI with midline shift of more than 5 mm and/or nausea, vomiting, altered consciousness, or clinically significant papilledema;
* catheter obstruction;
* predicted life expectancy less than 3 months;
* patients without preserved logical-verbal contact or uncooperative;
* inability to provide informed, voluntary consent to participate in the study;
* patients participating in another medical experiment;
* patients who have taken any other investigational drug within 1 month of the first dose;
* prior treatment with \[225Ac\]Ac-DOTA-SP;
* breastfeeding or pregnancy;
* severe diseases of other organs that, in the opinion of the Investigator, significantly increase the risk of the procedure.

Where it's running

• Department of Neurosurgery, Medical University of Warsaw, Banacha 1a
  Warsaw, Poland, Poland Recruiting
• Department of Neurosurgery, National Instiute of Oncology, W.K. Roentgena 5
  Warsaw, Poland, Poland Recruiting

Study contacts

• Principal investigator: Przemysław Kunert, Professor — Department of Neurosurgery, Medical University of Warsaw, Poland
• Study coordinator: Przemysław Kunert, Professor
• Email: przemyslaw.kunert@wum.edu.pl
• Phone: +48 22 599 2575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.