Integrated PET/MR Imaging With Amino Acid Radiotracers in the Evaluation of Brain Neoplasms: Assessing Diagnostic Accuracy and Therapeutic Response
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary and Secondary Brain Tumors. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Primary outcome measures
- Diagnostic accuracy of PET/MRI [Time frame: Conducted at approximately the end of the planned treatment course.]
- Clinical-radiological outcome [Time frame: Conducted at approximately the end of the planned treatment course]
- Histopathology outcome [Time frame: Conducted at approximately the end of the planned treatment course]
Eligibility criteria
Inclusion criteria
- Age 18-99.
- Diagnosis of primary or secondary brain tumors.
- Development of suspected lesions on MRI following treatment, with dimensions greater than one centimeter.
- Ability to undergo PET/MRI imaging sessions.
- Availability of clinical and follow-up data for correlation with imaging findings
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07211360 · 3426