Integrated PET/MR Imaging With Amino Acid Radiotracers in the Evaluation of Brain Neoplasms: Assessing Diagnostic Accuracy and Therapeutic Response

N/ANot Yet RecruitingNCT07211360

IRCCS San Raffaele270 enrolled

Overview

Evaluation of the diagnostic and prognostic role of PET with Amino Acid Radiotracers associated with simultaneous acquisition of MRI with administration of paramagnetic contrast medium based on Gadobutrol in assessing diagnostic accuracy and therapeutic response in adult individuals affected by primary and secondary brain tumors. This is a purely observational study that does not introduce any procedures beyond those already scheduled as part of routine clinical practice. All imaging procedures and clinical assessments will be performed exclusively within the standard care pathway. This study will analyze two cohorts of patients: 1\. Cohort A: Adult patients with primary or secondary brain tumors undergoing neuro-oncological therapy, presenting with lesions suspected to be either disease progression or post-treatment changes. 2\. Cohort B: Adult patients with a first diagnosis of primary or secondary brain tumor.

Study Type

OBSERVATIONAL

Enrollment

270

Conditions

Primary and Secondary Brain Tumors

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-99. 2. Diagnosis of primary or secondary brain tumors. 3. Development of suspected lesions on MRI following treatment, with dimensions greater than one centimeter. 4. Ability to undergo PET/MRI imaging sessions. 5. Availability of clinical and follow-up data for correlation with imaging findings 6. Signed informed consent from the patient Exclusion Criteria: .Patients under 18 years of age. 2.Absence of a confirmed diagnosis of primary or secondary brain tumors. 3.Lesions on MRI with dimensions smaller than one centimeter. 4.Inability to undergo PET/MRI imaging sessions (e.g., due to medical conditions such as pregnancy, allergies to contrast agents, or presence of incompatible implants or devices) 5.Unavailability of clinical and follow-up data for correlation with imaging findings. 6.Patients who are unable or unwilling to provide signed informed consent.

Outcomes

Primary Outcomes

Diagnostic accuracy of PET/MRI

Diagnostic accuracy of PET/MRI measured with sensitivity, specificity (calculated from the contingency table as follows: Sensitivity = True Positives / (True Positives + False Negatives) and Specificity True Negatives / (True Negatives + False Positives), positive and negative predicted value using clinical radiological or histopathology outcomes collected during standard clinical practice.

Time frame: Conducted at approximately the end of the planned treatment course.

Clinical-radiological outcome

it will be defined as disease progression if serial imaging shows a \>25% increase in lesion size or the appearance of new lesions, according to RANO or BTRADS criteria.

Time frame: Conducted at approximately the end of the planned treatment course

Histopathology outcome

it involves tissue biopsy results confirmed by pathology reports