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

NCT06830356 — Not applicable, Recruiting, 53 participants, Centro di Riferimento Oncologico - Aviano

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Registry	NCT06830356, acronym SPIDER-MEN
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	53 (Estimated)
Sponsor	Centro di Riferimento Oncologico - Aviano (Other)
Conditions	Meningioma
Interventions	Dose escalation of radiation therapy, based on somatostatin receptor PET imaging (Radiation)
Dates	start 2024-12-23, primary completion 2037-12-23 (estimated), completion 2037-12-23 (estimated), first posted 2025-02-17, last updated 2025-02-17
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Dose escalation of radiation therapy, based on somatostatin receptor PET imaging	Experimental	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

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

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 16 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Centro di Riferimento Oncologico di Aviano (CRO)	Aviano, Pordenone	Italy	Recruiting

+Investigators

Lorenzo Vinante, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO)