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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07211360
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	IRCCS San Raffaele
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary and Secondary Brain Tumors

Arms & Interventions

Arms

: 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

: cohort B

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

Interventions

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Rachele Di Donato

[email protected]

0226433639

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Clinical Trial Finder