A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 11-002165
NCT ID: NCT02104310
Sponsor Protocol Number: 11-002165
About this study
For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used to image the tumor and guide your radiation oncologist in determining locations to treat with radiation. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to use the 18F-DOPA PET/CT scan to help determine where the disease is that needs to be treated with radiation, in order to improve the effectiveness of radiation in this tumor.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Age ≥ 7 years.
- Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma.
- CT simulation, 18F-DOPA PET imaging, and standard of care pre-RT MRI scans to be performed at Mayo Clinic Rochester.
- Provide informed written consent.
- Patients diagnosed with WHO grade IV malignant glioma.
- Patients previously treated with radiation therapy.
- Unable to undergo MRI scans with contrast (e.g., cardiac pacemaker, defibrillator, kidney failure).
- Unable to undergo an 18F-DOPA PET scan (e.g., Parkinson’s Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists. Other potentially interfering drugs consist of: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline).
- Any of the following:
- Pregnant women;
- Nursing women;
- Men or women of childbearing potential who are unwilling to employ adequate contraception.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Nadia Laack, M.D.
Closed for enrollment
Publications are currently not available