Ireland
--:--IST
Recruiting Not applicable

Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.

NCT06830356 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-12-23
Last updated
2025-02-17

Condition(s) studied

Meningioma

Investigational drug(s) / intervention(s)

Dose escalation of radiation therapy, based on somatostatin receptor PET imaging

Dose escalation of radiation therapy, based on somatostatin receptor PET imaging: Radiation treatment with higher doses than the standard and defined using PET imaging

Study summary

High-risk meningiomas always require postsurgical radiation treatment. Recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. In order to better define the volume of radiation treatment, the addition of PET imaging with somatostatin receptor tracers adds additional information compared to encephalon MRI with MoC alone.The present study aims to investigate whether radiation treatment with higher doses than the standard and defined using PET imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 16 years; * Ability to express appropriate informed consent to treatment; * Diagnosis of grade III meningioma (regardless of presence of residual) or diagnosis of recurrence of grade II meningioma (regardless of presence of residual) or first diagnosis of grade II meningioma with presence of residual; * In case of recurrence, confirmation can be either histological or radiological; * Not previous brain-level radiotherapy; * Performance status: ECOG=0-2. Exclusion Criteria: * Refusal to radiation treatment (i.e., absence of signed informed consent); * Other concomitant oncologic therapies * Current pregnancy; * Grade I meningiomas or Grade II meningiomas if operated on at first diagnosis with radical resection; * Inability to perform MRI with MoC or PET.

Primary outcome measure(s)

  • Incidence of brain radionecrosis — up to 13 years
    Incidence of symptomatic brain radionecrosis (grade \>=2 defined according to CTCAE scale v5.0).
  • Assess progression free survival (progression free survival = PFS) at 3 years — up to 13 years
    Percentage of patients alive and free of disease progression at 3 years after the start of radiotherapy (PFS rate). Progression will be defined as increase in size of treated lesions or appearance of new lesions (according to RANO meningioma criteria)

Trial sites (1)

FacilityCityRegionStatus
Centro di Riferimento Oncologico di Aviano (CRO) Aviano Pordenone Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06830356 on ClinicalTrials.gov ↗ ← All trials in Italy