NCT06975332Toboroz
Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression
Medical Experiment - Assessment of Efficacy & Safety of Local, Targeted Therapy With Neuropeptide Labelled With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) as Supplementary Therapy in Glioma (WHO G3-G4) Progression
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 13.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 35 (tervezett)
- Első benyújtás
- 2025. ápr. 14.
- Kezdés
- 2024. okt. 9.
- Elsődleges befejezés
- 2027. szept.
- Fő szponzor
- Medical University of Warsaw
- Betegségek
- Glioblasztóma
- NCT-szám
- NCT06975332
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 35
- 2024. okt. 9. és az elsődleges befejezés (2027. szept.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- necessity of urgent surgery (e.g., sudden increase in intracranial pressure);
- open/communicating resection cavity;
- patients who have taken any other investigational drug within 1 month of the first dose;
- prior treatment with \[225Ac\]Ac-DOTA-SP;
Más betegség
- significant postoperative complications: e.g., Karnofsky's performance scale (KPS) \<70, wound infection, cerebrospinal fluid leak;
- severe diseases of other organs that, in the opinion of the Investigator, significantly increase the risk of the procedure.
Egyéb
- ventricular shunt leak \>10% during a control patency test;
- 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;
- breastfeeding or pregnancy;
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Department of Neurosurgery, National Instiute of Oncology, W.K. Roentgena 5 Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Warsaw | Lengyelország | Toboroz |
| Department of Neurosurgery, Medical University of Warsaw, Banacha 1a Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Warsaw | Lengyelország | Toboroz |
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