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

NCT ID: NCT07211360

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2031-09-30

Brief Summary

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.

Conditions

Primary and Secondary Brain Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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

No interventions assigned to this group

cohort B

Adult patients with a first diagnosis of primary or secondary brain tumor.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Chiti Arturo

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rachele Di Donato

Role: CONTACT

didonato.rachele@hsr.it

0226433639

Chiara Catalano

Role: CONTACT

catalano.chiara@hsr.it

0226433639

Other Identifiers

3426

Identifier Type: -

Identifier Source: org_study_id