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

Not Applicable

Recruiting

• Conditions: Meningioma

• Registration Number: NCT06830356
• Lead Sponsor: Centro di Riferimento Oncologico - Aviano

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-23
• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Primary Completion: 2037-12-23
• Study Completion: 2037-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Overall survival (Overall survival = OS)	up to 13 years	Overall survival (OS) will be defined as time between enrollment and death
Incidence of other toxicities	up to 13 years	Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0
Concordance between GTV-RM and GTV-PET	up to 13 years	Concordance will be measured according to Dice Similarity coefficient

Trial Locations

Locations (1)

Centro di Riferimento Oncologico di Aviano (CRO); 🇮🇹 Aviano, Pordenone, Italy