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Status:

RECRUITING

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

Lead Sponsor:

Medical University of Warsaw

Conditions:

Glioblastoma

High-Grade Gliomas

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

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...

Detailed Description

1. Background: Brain tumors account for 1.35% of all cancer conditions and cause deaths in 2.2% of cancer patients (Cancer Facts and Figures 2005). The most common type of brain tumors are gliomas. De...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    October 9 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2027

    Estimated Enrollment :

    35 Patients enrolled

    Trial Details

    Trial ID

    NCT06975332

    Start Date

    October 9 2024

    End Date

    September 1 2027

    Last Update

    May 16 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Department of Neurosurgery, Medical University of Warsaw, Banacha 1a

    Warsaw, Poland, Poland, 02-097

    2

    Department of Neurosurgery, National Instiute of Oncology, W.K. Roentgena 5

    Warsaw, Poland, Poland, 02-781