Local targeted alpha therapy using 225Ac‑DOTA‑SP for newly diagnosed WHO grade 3–4 glioma

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

Researchers deliver [225Ac]Ac‑DOTA‑SP directly into the tumor cavity or surrounding area after standard surgery and radiochemotherapy so the peptide can bind neurokinin‑1 receptors on glioma cells and emit highly localized alpha radiation. The study is a single‑arm interventional protocol enrolling adults with histologically confirmed WHO grade 3–4 glioma, Karnofsky performance status ≥70, and no imaging evidence of progression or radiation necrosis. Outcomes focus on safety and local tumor control with serial MRI and clinical follow‑up to monitor response and adverse events. Treatment is performed at specialist neurosurgical centers under radiation‑safety procedures.

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;
* 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.

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 MD PhD — Medical University of Warsaw
• Study coordinator: Przemysław Kunert, Professor MD PhD
• Email: przemyslaw.kunert@wum.edu.pl
• Phone: +48 22 599 2575

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brain connectome project in adults with brain glioma undergoing surgery

  This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.

  Recruiting Northwell Health · New York, New York · NCT07927595

• TLX101-Tx plus standard care versus standard care alone for recurrent glioblastoma

  This test checks whether adding TLX101-Tx, a tumor-targeted radiopharmaceutical given with lomustine, helps adults with first-recurrence glioblastoma control their tumor or live longer compared with lomustine alone.

  Recruiting at 7 sites Phase 3 Telix Pharmaceuticals (Innovations) Pty Limited · Gold Coast, Queensland and 8 other locations · NCT07100730

• Combining Lutathera® and Olaparib for treating recurrent solid tumors in children and adolescents

  This study is testing if combining Lutathera® with olaparib can help children and teenagers with hard-to-treat solid tumors that have certain receptors.

  Recruiting Phase 1/2 Fundación de investigación HM · Boadilla del Monte, Madrid · NCT06607692

• YN003 injection in glioma patients

  This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.

  Recruiting at 2 sites Phase 1 Beijing Inno Medicine Co., Ltd. · Los Angeles, California and 4 other locations · NCT07929909

• Lixumistat window of opportunity in newly diagnosed glioblastoma

  This study tests whether Lixumistat can benefit adults with newly diagnosed glioblastoma who are planned for surgical tumor removal.

  Recruiting Early Phase 1 University of Miami · Miami, Florida · NCT07884344

• Glioblastoma in Réunion: an epidemiological and socio-anthropological look at patients and care

  A large group of adults with diffuse gliomas in Réunion is being studied to understand how biology, culture, and health care pathways affect diagnosis and treatment.

  Recruiting Centre Hospitalier Universitaire de la Réunion · Saint-Pierre · NCT07865195

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.