Primary and Secondary Brain TumorsPETMR_ATHENA02NCT07211360
Integrated PET/MR Imaging With Amino Acid Radiotracers in the Evaluation of Brain Neoplasms: Assessing Diagnostic Accuracy and Therapeutic Response
An observational study of Primary and Secondary Brain Tumors, run by IRCCS San Raffaele.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Primary and Secondary Brain Tumors
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult individuals affected by primary and secondary brain tumors.
Who may be able to join
- 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
Who cannot join
- .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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
- 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.
- Conditions
- Primary and Secondary Brain Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Conducted at approximately the end of the planned treatment course
Histopathology outcome
it involves tissue biopsy results confirmed by pathology reports
Measured: Conducted at approximately the end of the planned treatment course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary and Secondary Brain TumorsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211360
- Sponsor's protocol ID
- 3426
- Acronym
- PETMR_ATHENA02
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated PET/MR Imaging With Amino Acid Radiotracers in the Evaluation of Brain Neoplasms: Assessing Diagnostic Accuracy and Therapeutic Response
- ClinicalTrials.gov ID
- NCT07211360
- Acronym / sponsor ID
- PETMR_ATHENA02 / 3426
- Conditions
- Primary and Secondary Brain Tumors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult individuals affected by primary and secondary brain tumors.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- .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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Histopathology outcome
Time frame: Conducted at approximately the end of the planned treatment course
it involves tissue biopsy results confirmed by pathology reports
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
Related trials for Primary and Secondary Brain Tumors
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
Brain Tumor, Primary, Brain Metastases, Adult
RecruitingPhase 1
IL-8 Receptor Modified Patient-Derived Activated CD70 CAR T Cell Therapy in Adults With Brain Metastases
Brain Metastases
RecruitingPhase 1
A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)
Recurrent Medulloblastoma, Refractory Medulloblastoma
Recruiting
BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.
Brain Metastases, Adult, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary and Secondary Brain Tumors, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachele Di Donato (0226433639, didonato.rachele@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of PET/MRI (time frame: Conducted at approximately the end of the planned treatment course.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.