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

NCT06830356 | Recruiting

• 1 other identifier: CRO-2024-47
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence of brain radionecrosis

  Incidence of symptomatic brain radionecrosis (grade \>=2 defined according to CTCAE scale v5.0).

  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)

  up to 13 years

Secondary Outcomes (3)

• Overall survival (Overall survival = OS)

  up to 13 years

• Incidence of other toxicities

  up to 13 years

• Concordance between GTV-RM and GTV-PET

  up to 13 years

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico di Aviano (CRO)

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• Lorenzo Vinante

  Centro di Riferimento Oncologico di Aviano (CRO)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Vinante

CONTACT

0434 659855; lorenzo.vinante@cro.it

Maurizio Mascarin

CONTACT

mascarin@cro.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: December 23, 2024
• Primary Completion (Estimated): December 23, 2037
• Study Completion (Estimated): December 23, 2037
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

IT (1)