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NCT Number: NCT06830356

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro di Riferimento Oncologico di Aviano (CRO)

Aviano, Pordenone, 33081, Italy

Location status: Recruiting

Location contact

Lorenzo Vinante, MD

CONTACT

Maurizio Mascarin, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Incidence of brain radionecrosis

    Time frame: up to 13 years

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

  2. Assess progression free survival (progression free survival = PFS) at 3 years

    Time frame: up to 13 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)

Secondary outcomes

  1. Overall survival (Overall survival = OS)

    Time frame: up to 13 years

    Overall survival (OS) will be defined as time between enrollment and death

  2. Incidence of other toxicities

    Time frame: up to 13 years

    Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0

  3. Concordance between GTV-RM and GTV-PET

    Time frame: up to 13 years

    Concordance will be measured according to Dice Similarity coefficient

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Vinante

CONTACT

[email protected]

0434 659855

Maurizio Mascarin

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Acronym: SPIDER-MEN

Important dates

Study start
2024
Primary completion
2037
Study completion
2037
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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