Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dose escalation of radiation therapy, based on somatostatin receptor PET imaging.
- Who it may be relevant to
- Registry conditions: Meningioma. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Incidence of brain radionecrosis [Time frame: up to 13 years]
- Assess progression free survival (progression free survival = PFS) at 3 years [Time frame: up to 13 years]
Secondary outcome measures (3)
- Overall survival (Overall survival = OS) [Time frame: up to 13 years]
- Incidence of other toxicities [Time frame: up to 13 years]
- Concordance between GTV-RM and GTV-PET [Time frame: up to 13 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Centro di Riferimento Oncologico di Aviano (CRO) — Aviano
Identifiers
NCT: NCT06830356 · CRO-2024-47