18F-DOPA PET/CT to guide care for adults with brain tumors
A Centralized Protocol Evaluating the Safety and Clinical Impact of Amino Acid Pet for Brain Tumors
This test tries whether adding 18F-DOPA PET/CT scans to standard imaging helps doctors manage care for adults with malignant brain tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06667726 on ClinicalTrials.gov |
What this trial studies
This Phase II trial adds an amino-acid PET tracer (18F-DOPA) to standard imaging to see if PET/CT changes clinical management in over half of adult brain tumor patients. Eligible adults receive an IV injection of 18F-DOPA followed by a 30-minute PET/CT scan, and treating clinicians review the PET/CT alongside routine MRI/CT. The primary goal is to measure how often the PET/CT changes management decisions; secondary goals include safety/tolerability and identification of tumor outside standard MRI. Patients are observed for three days after the scan for adverse events and to document any immediate changes in care.
Who should consider this trial
Good fit: Adults (18 and older) with a diagnosed brain tumor who have an indication for amino-acid PET (presurgical evaluation, radiation planning, indeterminate MRI for progression vs treatment effect, or enhanced monitoring) and can give informed consent are ideal candidates.
Not a fit: People who are pregnant or nursing, unable to undergo PET imaging, or whose treatment plan is already clearly defined by standard imaging may not receive benefit from this procedure.
Why it matters
Potential benefit: If successful, this approach could help doctors make more accurate treatment and surgical decisions by revealing tumor activity that standard MRI might miss.
How similar studies have performed: Prior studies of amino-acid PET tracers such as 18F-DOPA and FET have shown promise in better delineating tumor and distinguishing recurrence from treatment effect, but larger FDA-focused management-impact and safety data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 and older * Diagnosis of a brain tumor * Indication for amino acid PET imaging, including presurgical evaluation, radiation planning, MR imaging indeterminate for progression versus treatment effect, or clinical need for enhanced monitoring * Ability to give appropriate consent or have an appropriate representative available to do so Exclusion Criteria: * Patient is unable to undergo PET imaging * Persons who are pregnant or nursing
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Derek R. Johnson, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.