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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06830356
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centro di Riferimento Oncologico - Aviano
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lorenzo Vinante
Principal Investigator Affiliation	Centro di Riferimento Oncologico di Aviano (CRO)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Meningioma

Arms & Interventions

Arms

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

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

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

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