MeningiomaSPIDER-MENNCT06830356
Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.
A study testing Dose escalation of radiation therapy, based on somatostatin receptor PET imaging in people with Meningioma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Dose escalation of radiation therapy, based on somatostatin receptor PET imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 23 Dec 2024to 23 Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maurizio Mascarin contact
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico di Aviano (CRO)
Aviano, Pordenone, 33081
Lorenzo Vinante, MD
Maurizio Mascarin, MD
About this study
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
- Being tested
- Dose escalation of radiation therapy, based on somatostatin receptor PET imaging
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalation of radiation therapy, based on somatostatin receptor PET imagingRadiation
Radiation treatment with higher doses than the standard and defined using PET imaging
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Dose escalation of radiation therapy, based on somatostatin receptor PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of brain radionecrosis
Incidence of symptomatic brain radionecrosis (grade >=2 defined according to CTCAE scale v5.0).
Measured: 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)
Measured: up to 13 years
Secondary outcomes (3)
Overall survival (Overall survival = OS)
Overall survival (OS) will be defined as time between enrollment and death
Measured: up to 13 years
Incidence of other toxicities
Incidence of other neurological toxicities graded using the CTCAE scale v. 5.0
Measured: up to 13 years
Concordance between GTV-RM and GTV-PET
Concordance will be measured according to Dice Similarity coefficient
Measured: up to 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start23 Dec 2024
- Primary completion23 Dec 2037 (estimated)
- Study completion23 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Vinante, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830356
- Sponsor's protocol ID
- CRO-2024-47
- Acronym
- SPIDER-MEN
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.
- ClinicalTrials.gov ID
- NCT06830356
- Acronym / sponsor ID
- SPIDER-MEN / CRO-2024-47
- Conditions
- Meningioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 23 Dec 2037 (estimated)
- Study completion
- 23 Dec 2037 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation of radiation therapy, based on somatostatin receptor PET imaging | Experimental | Radiation: Dose escalation of radiation therapy, based on somatostatin receptor PET imagingRadiation treatment with higher doses than the standard and defined using PET imaging |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose escalation of radiation therapy, based on somatostatin receptor PET imagingRadiation treatment with higher doses than the standard and defined using PET imaging | Radiation | Dose escalation of radiation therapy, based on somatostatin receptor PET imaging |
Primary outcome
Incidence of brain radionecrosis
Time frame: up to 13 years
Incidence of symptomatic brain radionecrosis (grade >=2 defined according to CTCAE scale v5.0).
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)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maurizio Mascarin contact
Lorenzo Vinante principal investigator
Centro di Riferimento Oncologico di Aviano (CRO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose escalation of radiation therapy, based on somatostatin receptor PET imaging in people with Meningioma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Vinante (0434 659855, lorenzo.vinante@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of brain radionecrosis (time frame: up to 13 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.