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Recruiting NCT06830356

NCT06830356 Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.

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Clinical Trial Summary
NCT ID NCT06830356
Status Recruiting
Phase
Sponsor Centro di Riferimento Oncologico - Aviano
Condition Meningioma
Study Type INTERVENTIONAL
Enrollment 53 participants
Start Date 2024-12-23
Primary Completion 2037-12-23

Eligibility & Interventions

Sex All sexes
Min Age 16 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Dose escalation of radiation therapy, based on somatostatin receptor PET imaging

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 53 participants in total. It began in 2024-12-23 with a primary completion date of 2037-12-23.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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.

Contact & Investigator

Central Contact

Lorenzo Vinante

✉ lorenzo.vinante@cro.it

📞 0434 659855

Principal Investigator

Lorenzo Vinante

PRINCIPAL INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO)

Frequently Asked Questions

Who can join the NCT06830356 clinical trial?

This trial is open to participants of all sexes, aged 16 Years or older, studying Meningioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06830356 currently recruiting?

Yes, NCT06830356 is actively recruiting participants. Contact the research team at lorenzo.vinante@cro.it for enrollment information.

Where is the NCT06830356 trial being conducted?

This trial is being conducted at Aviano, Italy.

Who is sponsoring the NCT06830356 clinical trial?

NCT06830356 is sponsored by Centro di Riferimento Oncologico - Aviano. The principal investigator is Lorenzo Vinante at Centro di Riferimento Oncologico di Aviano (CRO). The trial plans to enroll 53 participants.

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