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MeningiomaNCT06180226

Evaluation of Brain Functional Changes With 18F-FDG PET and Cognitive Processes After Brain Radiotherapy for Cavernous Sinus Meningiomas and Non-secreting ACTH Adenomas

An observational study of Meningioma, run by IRCCS San Raffaele.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The use of radiotherapy for irradiation of all or part of the brain, in the treatment of extracerebral intracranial neoplasms, is growing rapidly, both due to the increase in diagnoses of primary tumors thanks to new imaging methods, and for the increase in the number of new cases of cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningioma
What is being tested?
PET CT with 18 FDG .
How many people
20 participants
Where
No sites listed yet
Study dates
21 Apr 2008to 11 Dec 2014
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients presenting with a cyto/histological diagnosis of cavernous sinus meningioma or intracranial and extracerebral neoplasia.

Who may be able to join

  • lesion dimensions compatible with a GAmma Knife treatment or tomotherapy;
  • adequate hematological, hepatic and renal function;
  • signed informed consent.

Who cannot join

  • patients < 18 years

About this study

The use of radiotherapy for irradiation of all or part of the brain, in the treatment of extracerebral intracranial neoplasms, is growing rapidly, both due to the increase in diagnoses of primary tumors thanks to new imaging methods, and for the increase in the number of new cases of cancer.

Cerebral neurotoxicity linked to radiation treatment is an adverse effect that is not always accurately evaluated based on the prognosis of some brain pathologies. The progression of diagnostic and therapeutic methods has recently generated a modification of therapeutic protocols and some categories of radiotreated patients may incur acute, subacute and late effects. These include manifestations of acute neurological deterioration, more frequently effects classified as sub-acute such as "somnolence syndrome" (from 2 to 6 weeks after the end of treatment) and finally late effects, which manifest themselves as a variety of neurological deficits in particular a decline in cognitive brain functions, probably linked to a direct effect on neurons or the result of an imbalance in the connections between white matter and cerebral gray matter. In relation to the myelin function of conduction of axonal transmission, the result of radio-induced damage in this site would manifest itself with a significant reduction in the speed of transmission of the impulse and consequently with a dramatic worsening of cognitive processes. In particular, clinically, radiologically and in some cases also from a pathological point of view, the damage from rays on the brain parenchyma would have aspects similar to those of a degenerative pathology such as Alzheimer's disease. These effects are usually measured on the patient by subjective assessments or using neuropsychological tests. The use, not only experimental, of neurophysiological methods for the study of cognitive processes in neurology and in degenerative disorders such as dementia is increasingly frequent. These methods are based on the study of specific neuronal circuits involved in the cognitive functions of the human brain in normal conditions and in the presence of pathology. Among the techniques that allow an analysis of molecular alterations in vivo there are scintigraphic ones, i.e. nuclear medicine ones, including single photon emission tomography (SPET) and positron emission tomography (PET).

Conditions
Meningioma
Being tested
PET CT with 18 FDG .
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET CT with 18 FDG .Diagnostic test

    Impact exerted by the use of 18FDG PET in the process of functional monitoring of the patient undergoing radiotherapy treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PET CT with 18 FDG in adult patients affected by extracerebral intracranial cavernous sinus meningioma.

    evaluation of the impact of the use of 18 FDG PET in the process of functional monitoring of patients undergoing radiotherapy treatment.

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2023
  2. Study start21 Apr 2008
  3. Primary completion11 Dec 2014
  4. Study completion11 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06180226
Sponsor's protocol ID
MENINGIOMA/RADIOTOSS
Status last verified
Dec 2023
First submitted
12 Dec 2023
Last updated
22 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Meningioma, run by IRCCS San Raffaele.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PET CT with 18 FDG in adult patients affected by extracerebral intracranial cavernous sinus meningioma. (time frame: 6 years). 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 22 Dec 2023.

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