Centro di Riferimento Oncologico di Aviano (CRO)
Aviano, Pordenone, 33081, Italy
Location status: Recruiting
Location contact
Lorenzo Vinante, MD
CONTACT
Maurizio Mascarin, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06830356
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.
Interested in participating?
Request Info16 year and older
All sexes
Interventional
Not applicable
Aviano, Pordenone, 33081, Italy
Location status: Recruiting
Lorenzo Vinante, MD
CONTACT
Maurizio Mascarin, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiation treatment with higher doses than the standard and defined using PET imaging
Time frame: up to 13 years
Incidence of symptomatic brain radionecrosis (grade >=2 defined according to CTCAE scale v5.0).
Time frame: 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)
Time frame: up to 13 years
Overall survival (OS) will be defined as time between enrollment and death
Time frame: up to 13 years
Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0
Time frame: up to 13 years
Concordance will be measured according to Dice Similarity coefficient
Contact information is provided by the study sponsor or research team.
Centro di Riferimento Oncologico - Aviano
Other
Acronym: SPIDER-MEN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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