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

NCT ID: NCT06830356

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-23
• Study Completion Date: 2037-12-23

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.

Conditions

Meningioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Radiation treatment with higher doses than the standard and defined using PET imaging

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

Radiation treatment with higher doses than the standard and defined using PET imaging

Interventions

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

Radiation treatment with higher doses than the standard and defined using PET imaging

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Vinante

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO)

Locations

Centro di Riferimento Oncologico di Aviano (CRO)

Aviano, Pordenone, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lorenzo Vinante

Role: CONTACT

lorenzo.vinante@cro.it

0434 659855

Maurizio Mascarin

Role: CONTACT

mascarin@cro.it

Facility Contacts

Lorenzo Vinante, MD

Role: primary

Other Identifiers

CRO-2024-47

Identifier Type: -

Identifier Source: org_study_id