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

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).

Study Overview

• Status: Completed
• Conditions: Meningioma
• Intervention / Treatment: Diagnostic test: PET CT with 18 FDG .

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients < 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 years

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2008
• Primary Completion (Actual): December 11, 2014
• Study Completion (Actual): December 11, 2014

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Adenoma; Meningioma; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: MENINGIOMA/RADIOTOSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No