Pilot Radioembolisation Clinical Trial Assessing Safety and Efficacy in Recurrent Glioma

Korábbi kezelés

• Prior treatment with VEGF inhibitors
• Prior re-irradiation for progressive or recurrent disease
• Any local (surgery or radiotherapy) or systemic anti-cancer therapy within 28 days prior to the planned dose of the investigational treatment
• Concurrent use of any anti-cancer therapies, investigational drugs, or biological agents not specified in the protocol
• Known hypersensitivity or allergy to 90Y-resin microspheres or any component of the investigational product

Más betegség

• Contraindications to catheter-based angiography, including but not limited to known bleeding disorders, significant vascular abnormalities precluding safe access, and severe allergy to contrast agents
• Any severe or uncontrolled medical condition that, in the investigator's judgement, would pose an unacceptable risk to the patient or interfere with protocol compliance
• Cognitive or psychiatric conditions that would limit the ability to provide informed consent or adhere to study procedures

Egyéb

• Multifocal glioma recurrence
• Tumour located in the posterior fossa or involving/risking critical subcortical structures (e.g. thalamus, hypothalamus, basal ganglia, internal capsule, cerebral peduncle, midbrain, brainstem, or optic pathways)
• Contraindications to MRI, including but not limited to non-compatible implantable devices or severe claustrophobia
• Pregnancy or breastfeeding. Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during the study and for at least 4 months after the last procedure.

• Age ≥18 years at the time of screening
• Histomolecular diagnosis of IDH-wildtype glioblastoma (as per WHO 2021)
• Prior treatment with radiotherapy and an alkylating agent
• Presence of measurable disease on brain MRI, as defined by RANO 2.0 criteria
• Radiologically confirmed disease progression as per RANO 2.0 criteria
• Lesion confined to a single focus, with a maximum diameter ≤6 cm, and located in a vascular territory amenable to selective intra-arterial catheterisation as assessed on baseline imaging and confirmed by planning angiography, cone beam CT, and [99mTc]Tc-MAA SPECT/CT (where available)
• Stable neurological status; patients with epilepsy may be included if seizures are controlled on a stable dose of anti-epileptic medication
• ECOG performance status 0-2
• Estimated life expectancy of ≥3 months, in the opinion of the investigator
• Adequate haematologic, renal, hepatic, and coagulation function at screening, defined as:
  • Haemoglobin ≥9 g/dL
  • Absolute neutrophil count ≥1.5 x 109/L
  • Platelet count ≥100 x 109/L
  • Serum creatinine ≤1.5 x ULN, or creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
  • Total bilirubin ≤1.5 x ULN (except patients with known Gilbert's syndrome)
  • Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5 x ULN
  • International normalized ratio (INR) ≤1.5 x ULN
  • Prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN
• Ability to understand and comply with study requirements and provide written informed consent.