NCT Number: NCT07211360
Integrated PET/MR Imaging With Amino Acid Radiotracers in the Evaluation of Brain Neoplasms: Assessing Diagnostic Accuracy and Therapeutic Response
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.
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–99 year
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Diagnostic accuracy of PET/MRI
Time frame: Conducted at approximately the end of the planned treatment course.
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.
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Clinical-radiological outcome
Time frame: Conducted at approximately the end of the planned treatment course
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.
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Histopathology outcome
Time frame: Conducted at approximately the end of the planned treatment course
it involves tissue biopsy results confirmed by pathology reports
Study contacts
Contact information is provided by the study sponsor or research team.
Chiara Catalano
CONTACT
Rachele Di Donato
CONTACT
Sponsors and collaborators
Lead sponsor
IRCCS San Raffaele
Other
Registry information
Acronym: PETMR_ATHENA02
Important dates
- Study start
- 2025
- Primary completion
- 2028
- Study completion
- 2031
- First posted
- Oct 7, 2025
- Registry last updated
- Oct 7, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.