An interventional study of Dose escalation of radiation therapy, based on somatostatin receptor PET imaging in Meningioma, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 1 site in Italy. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Centro di Riferimento Oncologico - Aviano · Not applicable, Interventional, and Treatment
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.
233 studies on the registry are indexed under Meningioma; 90 are open to participants now.
This study's planned enrollment of 53 is above the median of 40 across 167 interventional studies indexed under Meningioma.
Browse Meningioma studies →Centro di Riferimento Oncologico - Aviano is the lead sponsor of 50 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Radiation treatment with higher doses than the standard and defined using PET imaging
Radiation: Dose escalation of radiation therapy, based on somatostatin receptor PET imaging
Radiation treatment with higher doses than the standard and defined using PET imaging
Incidence of brain radionecrosis
Incidence of symptomatic brain radionecrosis (grade \>=2 defined according to CTCAE scale v5.0).
Time frame: up to 13 years
Assess progression free survival (progression free survival = PFS) at 3 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)
Time frame: up to 13 years
Overall survival (Overall survival = OS)
Overall survival (OS) will be defined as time between enrollment and death
Time frame: up to 13 years
Incidence of other toxicities
Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0
Time frame: up to 13 years
Concordance between GTV-RM and GTV-PET
Concordance will be measured according to Dice Similarity coefficient
Time frame: up to 13 years
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Centro di Riferimento Oncologico - Aviano