Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07488754

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

Led by Medical University of Warsaw · Updated on 2026-04-06

35

Participants Needed

2

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 aged 18-80 with WHO G3-G4 glioma post-first-line treatment, not requiring immediate surgery and meeting specific MRI 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Histologically confirmed diffuse glioma classified as WHO grade 3 or 4
  • Completed standard treatment including biopsy or resection, radiotherapy, and/or chemotherapy
  • No signs of tumor progression or radiation necrosis
  • Functional status greater than 70 on the Karnofsky Performance Scale
  • Ability to provide informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Diagnosis of low-grade glioma
  • Evidence of tumor progression or recurrence based on clinical deterioration or MRI findings
  • Radiation-induced necrosis within the first 3 months after radiotherapy (except after resection and follow-up MRI)
  • Need for emergency surgery due to acute conditions
  • Significant postoperative complications such as Karnofsky Performance Status below 70, wound infection, or cerebrospinal fluid leak
  • More than 10% leak into the ventricular system during catheter check
  • Open or ventricle-connected resection cavity
  • Catheter obstruction
  • Estimated life expectancy under 3 months
  • Lack of preserved logical or verbal contact
  • Inability or unwillingness to cooperate or give informed consent
  • Enrollment in another medical trial
  • Receipt of any investigational drug within 1 month prior to treatment
  • Previous treatment with [225Ac]Ac-DOTA-SP
  • Pregnancy or breastfeeding
  • Severe organ diseases increasing procedural risk as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 2 locations

1

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

Warsaw, Poland, Poland, 02-097

Actively Recruiting

2

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

Warsaw, Poland, Poland, 02-781

Actively Recruiting

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Research Team

P

Przemysław Kunert, Professor MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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