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Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) In Newly Diagnosed Glioma (WHO G3-G4)

RecruitingNAAges 18 Years - 80 YearsAllMedical University of Warsaw
NCT07488754 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 age

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * low-grade glioma; * 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); * 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); * significant postoperative complications, e.g., KPS \< 70, wound infection, cerebrospinal fluid leak; * leak into the ventricular system \>10% during the catheter patency check; * open/ventricle-connected resection cavity; * 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; * patients who received any other investigational drug within 1 month prior to the first dose; * prior treatment with \[225Ac\]Ac-DOTA-SP; * breastfeeding or pregnant women; * severe comorbid organ diseases that, in the Investigator's opinion, significantly increase the procedural risk.
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What it tests

  • Radiation: Local, targeted therapy with alpha emitter [225Ac]Ac-DOTA-SP (TAT)
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Where

2 sites
Department of Neurosurgery, Medical University of Warsaw, Banacha 1a
Warsaw, Poland
Department of Neurosurgery, National Instiute of Oncology, W.K. Roentgena 5
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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